MAUDE Adverse Event Report: STRYKER GMBH REPOSITIONING FORCEPS L130MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702926
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2018
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
It was reported that the tip of the repositioning forceps was broken when crimping the fracture part during operation with variax fibula.Therefore, it was changed the new other forceps and the operation was succeeded.The surgeon's opinion that the bone quality of the patient was good and the forceps was excessive twisted.The broken part was removed and it was not left in the patient body.
Event or Problem Description
It was reported that the tip of the repositioning forceps was broken when crimping the fracture part during operation with variax fibula.Therefore, it was changed the new other forceps and the operation was succeeded.The surgeon's opinion that the bone quality of the patient was good and the forceps was excessive twisted.The broken part was removed and it was not left in the patient body.
Additional Manufacturer Narrative
Correction to concomitant medical products and device evaluated by mfr.The reported event that repositioning forceps l130mm was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device was not returned.

• Brand Name: REPOSITIONING FORCEPS L130MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8122207
• Report Number: 0008031020-2018-01018
• Device Sequence Number: 1770958
• Product Code: LXH
• UDI-Device Identifier: 04546540401519
• UDI-Public: 04546540401519
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 702926
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 21 YR