MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2014-08-15 for IN SITU BENDER-RIGHT 388.112 manufactured by Synthes Tuttlingen.
[4878567]
It was reported that during surgery utilizing the in-situ benders, the bender tips splayed open. The surgery included 5. 5 mm rods in a deformity construct in levels t6-s2. The case resumed with the construct complete, and without delay or complications for the patient. There were no fragments and the patient outcome was good. The damaged tips were first noticed postoperatively, during cleaning of the instruments. This report is for the right side bender this is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11987381]
Device was used for treatment, not diagnosis. Additional common device name: hxw. Device is an instrument and is not implanted/explanted. The investigation could not be completed; no conclusion could be drawn, as no product was received. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[31034863]
A review of the device history records has been requested. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[33237482]
Device was used for treatment, not diagnosis. The device history record review could not be performed as the records could not be identified as device is over 9 years old. The visual inspection of the returned device performed as part of the product investigation reported the part was received with the slot opening at the curved end bent open. Material deformation is evident at both openings. One in situ rod bender right (part# 388. 112 lot# a7qa28) and one in situ rod bender left (part# 388. 113 lot# a7qa28) were returned for the tips reportedly bending open. The benders are included in uss, pangea, and click? X systems for in situ sagittal plane bending of rods. Alternatively, rod benders 388. 91, 388. 92, 388. 112, 388. 113, 388. 117, 388. 961, 03. 620. 020, 03. 622. 060, 03. 622. 061, and 03. 622. 062 may be used to achieve contouring of the rods (technique guides: j4437-b, j7243-b, j6418-c, j5462-b, j9009-b, j6718-a). Product drawings 388_112 rev c and 388_113 were reviewed during the investigation. Both instruments have the slot opening, where the instrument is placed around the rod, bent open. The openings have yielded material along the lateral half suggesting that the instrument may not have been fully seated around the rod when used. Multiple areas of material deformation at the opening also indicate that excessive force may have been used repeatedly. Both benders are made from h900 heat treated 17-4ph and is appropriate for the intended use of the instruments as h900 provides maximum hardness. Wear coupled with user technique may have caused the complaint condition however the user technique is unknown and so the root cause is indeterminate. Review of the product drawings found the material, dimensions, tolerances and finishing process of the instruments adequate for their intended use. The complaint may be a result of gradual wear, applying excessive bending force or user technique although it cannot be definitively determined which contributed to the complaint condition. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2014-13168 |
| MDR Report Key | 4013052 |
| Report Source | 00,07 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-07-23 |
| Date of Event | 2014-07-23 |
| Date Mfgr Received | 2014-09-02 |
| Device Manufacturer Date | 2005-07-11 |
| Date Added to Maude | 2014-08-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IN SITU BENDER-RIGHT |
| Generic Name | INSTR., BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2014-08-15 |
| Returned To Mfg | 2014-08-04 |
| Catalog Number | 388.112 |
| Lot Number | A7QA28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN PA 19380785 GM 19380 7853 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-15 |