MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2015-05-05 for BENDING IRON FOR 2.7MM & 3.5MMRECONSTRUCTION PLATES 329.07 manufactured by Synthes Bettlach.
[5885718]
Device report from synthes (b)(4) reported the peg was broken on bending iron for 2. 7mm & 3. 5mm reconstruction plates. No further information was provided. No reported patient or procedure harm was noted. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13261347]
Additional narrative: patient information/involvement was not reported. Event date: unknown. 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. A review of the device history records has been requested. 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
[27261908]
Product investigation summary: the complaint condition for the 329. 07 lot number 2015 bending iron, for 2. 7mm and 3. 5mm reconstruction plates was likely caused by over twenty seven years of use; however, this complaint is most likely not a result of any design related deficiency. The bending irons for 2. 7mm and 3. 5mm reconstruction plates are instruments routinely used in the small fragment locking compression plate system and the only plate bender for reconstruction plates included in the set. The device was returned and reported that one of the pegs was broken. This condition is confirmed; the peg which seats in the plate hold during contouring has sheared off leaving a homogenous fracture surface. It is likely that over twenty seven years of use has led to this complaint condition. The device was manufactured in august, 1987 and is over twenty seven years old. The balance of the returned device is in otherwise surprisingly good condition give its age. The associated drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended. Device 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
| Report Number | 2520274-2015-13587 |
| MDR Report Key | 4747527 |
| Report Source | 01,07 |
| Date Received | 2015-05-05 |
| Date of Report | 2015-03-23 |
| Date Mfgr Received | 2015-07-07 |
| Device Manufacturer Date | 1987-08-20 |
| Date Added to Maude | 2015-05-05 |
| 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 BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDING IRON FOR 2.7MM & 3.5MMRECONSTRUCTION PLATES |
| Generic Name | INSTR, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2015-05-05 |
| Returned To Mfg | 2015-05-11 |
| Catalog Number | 329.07 |
| Lot Number | 2015 |
| 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 BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH PA 19380CH2 SZ 19380 CH25 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-05 |