MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER T25/SELF-RETAINING; SCREWDRIVERS

Catalog Number 03.010.107

Device Problem Device-Device Incompatibility (2919)

Patient Problem Injury (2348)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the open reduction internal fixation (orif) surgery for femoral trochanteric fractures with the expert humeral nail system.During the surgery, after the surgeon inserted the expert humeral nail and inserted a spiral blade, he inserted the locking screw at the proximal end.After insertion of the locking screw, the surgeon tried to pull out the screwdriver, but the locking screw was pulled out with the screwdriver.As a result, the surgeon did not insert the locking screw due to the thread inside the bone possibly being destroyed.The surgery was completed without any delay.The surgeon comments that this event may have been caused by a stronger engagement of the screw head to the screwdriver than usual and a poor bone quality of the patient as well.The patient was reported as stable after the surgery.Concomitant devices reported: nail head elements (part number unknown, lot unknown, quantity 1), nails: expert humeral (part number unknown, lot unknown, quantity 1), 4.0mm ti locking screw w/t25 stardrive 34mm f/im nails-ster (part number 04.005.424s, lot l204318, quantity 1).This report involves one (1) stardrive screwdriver t25/self-retaining.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: upon visual inspection of the complaint device it can be seen that the screwdriver is in a good condition for his age, with just a few scratches and dents from regular use through its 15 years of lifespan.Functional test: during investigation a functional test was performed.The screw and the screwdriver passed the functional test, as we are able to attach and detach the screw from the screwdriver.Dimensional inspection: the article has passed the function test, no issue could be confirmed, and therefore no dimensional inspection is needed.Document/specification review: drawings and revisions are in accordance to dhr of production lot 1310504.All relevant features are defined on the used drawing revisions of dhr of production lot 1310504.Summary: the review of the production history revealed that this item was manufactured in february 2005 according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.The complaint is rated as unconfirmed and not valid from manufacturing point of view, as the part is fully functional.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part: 03.010.107, lot: 1310504 , manufacturing site: hägendorf, release to warehouse date: 18.Feb.2005.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.

• Brand Name: STARDRIVE SCREWDRIVER T25/SELF-RETAINING
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10212561
• MDR Text Key: 197183197
• Report Number: 8030965-2020-04557
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 07611819760950
• UDI-Public: (01)07611819760950
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.107
• Device Lot Number: 1310504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 07/15/2020
• Supplement Dates FDA Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø4 L34 F/NAILS TAN DBLUE; UNK - NAIL HEAD ELEMENTS; UNK - NAILS: EXPERT HUMERAL
• Patient Outcome(s): Required Intervention