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

Catalog Number	705019-1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/01/2019
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 the temporary plate fixator pin broken during the operation.The broken tip is in the patient's body and unable to be removed.The procedure was completed successfully, and no adverse consequences or surgical delay were reported.
Event or Problem Description
It was reported that the temporary plate fixator pin broken during the operation.The broken tip is in the patient's body and unable to be removed.The procedure was completed successfully, and no adverse consequences or surgical delay were reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection of the device revealed the following: the device is generally in a good state, aside from the fact that it is broken at the tip.The material color looks slightly faded, probably due to multiple cleaning/sterilization cycles.The microscopic evaluation of the product shows clear torque lines on the surface of the breakage.These torque lines are the indicator that the material broke due to over-torque.As a reminder, the ifu clearly reminds the user: "always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry." furthermore, it is important to point out that this product has been in use since 2015.Almost 4 years of use could have contributed to the weakening of the material, and made it easier to break.As a conclusion, this case could be classified as both user and wear related.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.If any further information is provided, the investigation 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 ; CH 2545
• MDR Report Key: 8537010
• Report Number: 0008031020-2019-00366
• Device Sequence Number: 313678
• Product Code: LXH
• UDI-Device Identifier: 07613327093407
• UDI-Public: 07613327093407
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 05/22/2019

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: 705019-1
• Device Lot Number: 03552J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1