MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-07-15 for SLOTTED MALLET PDL102 manufactured by Synthes Tuttlingen.
[4534085]
It was reported that during revision surgery, l2-s1 posterior fusion with l2-3 transforaminal posterior lumbar interbody fusion (t-plif) and l5-s1 tplif, multiple parts did not function as intended while inserting the new screw system. The simple persuader got stuck, jammed, on the screw and the surgeon had to pry it open to get it off the screw head. Another simple persuader was available to use as backup. The straight shaft (straight tip stardriver) used during final tightening kept slipping off the locking cap. Another straight tip stardriver was available to use as backup. The screwdriver, (sport grip stardriver) would not hold the locking caps. The surgeon attempted to use the backup screwdriver, but that also would not hold the locking caps. The surgeon used bone wax with the screwdriver to make the locking caps stick. In addition, the mallet broke. After impacting the interbody, the technician noticed that the plastic portion could easily separate from the mallet. The threads inside the mallet were stripped. The fragment that was generated from the mallet breaking was in the mallet and was easily removed and discarded. The surgeon used the metal side of the mallet to finish the work. The revision surgery was being performed because the patient had adjacent level disease at l3-l4 and the surgeon wanted to replace the old click? X screw system with the new matrix screw system. A time delay of two minutes was reported. No patient harm was reported during the revision surgery. This is report 10 of 10 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11915123]
Device is an instrument and is not implanted/explanted. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. The raw material is corresponding to the specifications. The hardness was measured at the time of the manufacturing and was found to be good. No non-conformance reports were generated during production. Service history review: lot #a7oa46 no service history review can be performed because the lot number cannot be traced. The service history evaluation is unconfirmed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[12742947]
Additional narrative: 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
| Report Number | 9680938-2014-10037 |
| MDR Report Key | 3936749 |
| Report Source | 05,07 |
| Date Received | 2014-07-15 |
| Date of Report | 2014-06-16 |
| Date of Event | 2014-06-16 |
| Date Mfgr Received | 2014-06-26 |
| Device Manufacturer Date | 2006-02-06 |
| Date Added to Maude | 2014-07-28 |
| 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 | SLOTTED MALLET |
| Generic Name | HAMMER,SURGICAL |
| Product Code | HXL |
| Date Received | 2014-07-15 |
| Returned To Mfg | 2014-06-26 |
| Catalog Number | PDL102 |
| Lot Number | A7OA46 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-15 |