MAUDE Adverse Event Report: STRYKER GMBH CLOSED TUBE CLIP GAMMA3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200125
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
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
Tip is partially broken off during sterilization test.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned broken as reported.The device inspection revealed the following: as reported, the tip is broken.The fragment was not returned, but its size is significant.Such breakage could only have occurred due to careless handling of the device.However, based on the device inspection and the information provided, it was not possible to identify the exact cause of the breakage.As this was observed inside of sterilization department, it is unknown when or where the event occurred.This breakage could be a result of excessive force applied during the operation, a fall on the floor, or even handling issues during transportation or sterilization due to impaction with other devices.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to an user related issue.The failure was caused by careless handling of the device, most likely either during surgery, transportation or sterilization.As a reminder, the instructions for use state that: during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.Do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate! if more information is provided, the case will be reassessed.
Event or Problem Description
Tip is partially broken off during sterilization test.

• Brand Name: CLOSED TUBE CLIP GAMMA3
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19912050
• Report Number: 0009610622-2024-00730
• Device Sequence Number: 18311273
• Product Code: LXH
• UDI-Device Identifier: 04546540508003
• UDI-Public: (01)04546540508003(11)220922(10)K0BFBA
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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: Other
• Device Catalogue Number: 13200125
• Device Lot Number: K0BFBAA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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