MAUDE Adverse Event Report: STRYKER GMBH TEMP. PLATE FIXATOR PIN AO FITTING; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	705019-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/11/2020
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
As reported: "fracture repair of the left femur.The tip of the drill broke during the operation.The broken tip remained in the patient's bone.The patient was young and had good bone quality.".
Event or Problem Description
As reported: "fracture repair of the left femur.The tip of the drill broke during the operation.The broken tip remained in the patient's bone.The patient was young and had good bone quality.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received temp.Plate fixator pin was found to be damaged.The distal end or tip of the fixator pin is broken, and some wear marks were also found on the surface of the pin.The breakage of the tip seems to be a forceful fracture while drilling it forcefully in a relatively harder bone.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 material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use states: ¿always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The design of the instrument must not be modified in any way.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused by drilling the instrument forcefully in a relatively harder bone of a young patient.If any further information is provided, the complaint report will be updated.

• Brand Name: TEMP. PLATE FIXATOR PIN AO FITTING
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10631920
• Report Number: 0008031020-2020-02289
• Device Sequence Number: 17048971
• Product Code: LXH
• UDI-Device Identifier: 07613327093407
• UDI-Public: 07613327093407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/16/2020

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 Model Number: 705019-1
• Device Catalogue Number: 705019-1
• Device Lot Number: 00755V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1