MAUDE Adverse Event Report: SYNTHES GMBH INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM; SCREWDRIVERS

Catalog Number	03.010.472
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.Investigation summary: visual inspection: the inter-lock screwdriver combined t25/hexa (p/n: 03.010.472, lot #: l545273) was received at us cq.Upon visual inspection of the complaint device, the tip of the device was observed to be twisted.The received condition of the devices is consistent as an end of life indicator for the devices.No other issues were identified during the inspection.The received condition is consistent with the complaint condition thus the complaint is confirmed.Conclusion: after a visual inspection per guidance provided in windchill document, it is determined that the reusable instruments are worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # 03.010.472, lot # l545273, release to warehouse date: sep 13, 2017, manufacturing site: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformance 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, three (3) inter-lock screwdrivers were found to be dented on the tips.It was reported as being a sign of normal wear and tear.There was no patient or surgical involvement.There is no further information available.This report is for one (1) inter-lock screwdriver t25/3.5mm hex/330mm.This is report 1 of 3 for (b)(4).

• Brand Name: INTER-LOCK SCREWDRIVER T25/3.5MM HEX/330MM
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12339010
• Report Number: 8030965-2021-06810
• Device Sequence Number: 16894499
• Product Code: HXX
• UDI-Device Identifier: 07611819464032
• UDI-Public: (01)07611819464032
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/21/2021

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: 03.010.472
• Device Lot Number: L545273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1