MAUDE Adverse Event Report: SYNTHES GMBH SCREWDRIVER SHAFT STARDRIVE 165MM

Catalog Number	03.113.019
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a synthes employee.Part # 03.113.019 lot # 9255344 manufacturing site: (b)(4) release to warehouse date: 02 dec2014 supplier: synthes (b)(4) a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Customer quality investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting the images provided, the complaint condition was not confirmed as no issue could be determined due to the poor quality of the images.Also, a functional assessment was not able to perform since the device was not returned.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint could not be confirmed during photo investigation.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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 (b)(6) reports an event as follows: it was reported that on (b)(6), 2021 that the sizer would not grip the cortex to measure and the stardrive was too worn to grip the screw.Concomitant medical products: unk - screw (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) screwdriver shaft stardrive 165mm.This is report 2 of 2 for (b)(4).

• Brand Name: SCREWDRIVER SHAFT STARDRIVE 165MM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12674744
• Report Number: 8030965-2021-08872
• Device Sequence Number: 13754621
• Product Code: HXX
• UDI-Device Identifier: 07611819369573
• UDI-Public: 07611819369573
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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: 03.113.019
• Device Lot Number: 9255344
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/21/2021
• 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: DEPTH GAUGE F/LONG-SCR Ø3.5 MEAS-RANGE U; UNK - SCREWS: TRAUMA