MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING; SCREWDRIVERS

Catalog Number	314.152
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report source : other.The device was 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent the removal surgery with the screwdriver shaft and handle.Before the device delivery, the agency confirmed that the screwdriver shaft and handle were not connected properly and were disassembled easily.The surgery was completed with new set successfully without any surgical delay.The patient outcome was unknown.No further information is available.This complaint involves two (2) devices.This report is for (1) 3.5mm hexagonal screwdriver shaft self-retaining.This is report 1 of 2 (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.According to the information received, the patient underwent the removal surgery with the screwdriver shaft and handle.Before the device delivery, the agency confirmed that the screwdriver shaft and handle were not connected properly and were disassembled easily.The agency judged them to be defect products and arranged the other product by a charter.Since the newly arranged products were connected without any problem, it was delivered and there was no problem with the operation.The surgery was completed successfully without any surgical delay.We went attention to the sales rep to comply with the prescribed reporting date.No further information is available the product was returned to zuchwil customer quality for evaluation.Customer quality then conducted visual inspection, dimensional and functional check of the returned device.During the visual inspection it was detected, that the device was found in a used condition.Moreover the tip is in a used condition and the coupling end shows a deep mark.No other visual damage could be observed.The function test at zuchwil customer quality was conducted with received quick coupling handle.It was not possible to attach the screwdriver shaft to the handle.Hence, the complaint condition could be replicated.It should be noted that product failure is multifactorial.According to the functional check outcome, the device was not functional which does confirm the reported complaint condition.Further investigation on the handle has shown that the handle is fully functional as per design intended.Therefore, it is certain that the screw driver shaft has lost its functionality due to the marks at the coupling end.A manufacturing related issue can be excluded.As part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.Device history lot part: 314.152, lot: 19p6969 , manufacturing site: bettlach, release to warehouse date: nov.21, 2019.A manufacturing record evaluation was performed for the finished device 314.152 lot: 19p6969 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: 3.5MM HEXAGONAL SCREWDRIVER SHAFT SELF-RETAINING
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11310704
• Report Number: 8030965-2021-00938
• Device Sequence Number: 1166559
• Product Code: HXX
• UDI-Device Identifier: 07611819248489
• UDI-Public: (01)07611819248489
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 314.152
• Device Lot Number: 19P6969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/27/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE W/QUICK-COUPL