MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER T25 W/ COUPLING FOR 03.019.019/330MM; SCREWDRIVERS

Catalog Number	03.019.020
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(b)(4).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 or Problem Description
Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for left humerus shaft fracture with multiloc humeral nailing system.During screw insertion to the second distal hole, the screw could not be inserted further when it reached the contralateral bone and the screwdriver slipped.The surgeon tried to insert screws into another hole, but the screws could not be inserted.The surgery was delayed by forty-five (45) minutes.No further information is available.Concomitant device reported: screw (part unknown, lot unknown, quantity 1).This report is for a screwdriver.This is report 1 of 3 for (b)(4).
Additional 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.H3, h6: investigation summary investigation selection investigation site: cq zuchwil selected flow: damaged.Visual inspection: the received screwdriver is in a used condition slight sign of wear.Summary: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.The root cause was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.Based on the investigation findings of the returned two locking screws, we assume that screwdriver slipped, since the screws couldn¿t screwed further (as they came excessively in contact with the nail).Based on our investigations a product related fault can be excluded.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.H3, h4, h6: a review of the device history record device history lot , part: 03.019.020, lot: 9777654, manufacturing site: haegendorf, release to warehouse date: 18.Jan.2016.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 W/ COUPLING FOR 03.019.019/330MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8893297
• Report Number: 8030965-2019-67227
• Device Sequence Number: 318815
• Product Code: HXX
• UDI-Device Identifier: 07611819427204
• UDI-Public: (01)07611819427204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.019.020
• Device Lot Number: 9777654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention