MAUDE Adverse Event Report: STRYKER GMBH SCREWDRIVER BLADE T10 AO, SELF RETAINING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703880
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
The tip of the 703880 screwdriver was broken while tightening the screw during surgery.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: during visual inspection the tip of the screwdriver was observed completely broken.Rubbing marks observed on the tip of the screwdriver indicating excess contact with the mating part while turning.The breakage surface shows lines or ridges that radiate from the origin of the crack in a fan like pattern due to excess torsional force resulting in a brittle fracture.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with the values in the material specification.A review of the device history for the reported lot number did not indicate any abnormalities.No corrective actions are currently required.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were observed during the investigation.Based on the investigation, the root cause was attributed to a user related issue.The event was caused by application of excess torsional force exceeding the bearing capacity of the screwdriver resulting in a brittle failure.If additional information is provided, the case will be reassessed.
Event or Problem Description
The tip of the 703880 screwdriver was broken while tightening the screw during surgery.

• Brand Name: SCREWDRIVER BLADE T10 AO, SELF RETAINING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19709565
• Report Number: 0008031020-2024-00263
• Device Sequence Number: 3116149
• Product Code: LXH
• UDI-Device Identifier: 07613327069907
• UDI-Public: 07613327069907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 703880
• Device Lot Number: 1000322283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown