MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CLOSED TUBE CLIP GAMMA3®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13200125
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that, before surgery, the staff of the operation room noticed that the tip of the clip was broken.The subsequent procedure was completed successfully, and no surgical delay or adverse consequences were reported.
Event or Problem Description
It was reported that, before surgery, the staff of the operation room noticed that the tip of the clip was broken.The subsequent procedure was completed successfully, and no surgical delay or adverse consequences were reported.
Additional Manufacturer Narrative
The reported event that could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the device received is broken from the proximal part.The chipped off material is not available for evaluation, but the kind of breakage as seen in the received device indicates development of internal stress during previous surgeries probably due to due to impact which later propagated and resulted in cracking during sterilization process.Also, signs of intense usage are also visible.Based on the above facts the root cause of the reported event is due to changes in the structural integrity of the device after frequent sterilization cycles which is accentuated by improper handling by user.The device had been in use for a long time (manufactured in 2013), therefore it can be safely said that it had fulfilled its tasks in former surgeries as intended.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: CLOSED TUBE CLIP GAMMA3®
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8537088
• Report Number: 0009610622-2019-00210
• Device Sequence Number: 19447489
• Product Code: LXH
• UDI-Device Identifier: 04546540508003
• UDI-Public: 04546540508003
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2019

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: 13200125
• Device Lot Number: K09A06B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 08/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1