MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL RASP FOR XFUSE, SIZE S & XS X FUSE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	XRP002001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
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
A resident at the hospital, reported the following event : "tip of the proximal rasp broke and remained blocked in the phalanx.Procedure time delayed, change of osteosynthesis material, increase of the upper limb tourniquet time.
Additional Manufacturer Narrative
The reported event that proximal rasp for xfuse, size s & xs x fuse was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by overloading and aging of an instrument.The device was manufactured more than 10 years ago and has successfully been used during this timeframe.Therefore we can consider it has reached the end of its serviceable life.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.Stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date.See appendix 2 for further details.
Event or Problem Description
A resident at the hospital, reported the following event: "tip of the proximal rasp broke and remained blocked in the phalanx.Procedure time delayed, change of osteosynthesis material, increase of the upper limb tourniquet time.

• Brand Name: PROXIMAL RASP FOR XFUSE, SIZE S & XS X FUSE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7433416
• Report Number: 0008031020-2018-00295
• Device Sequence Number: 16456845
• Product Code: LXH
• UDI-Device Identifier: 07613252266532
• UDI-Public: (01)07613252266532
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/04/2018

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: XRP002001
• Device Catalogue Number: XRP002001
• Device Lot Number: 07171-10-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2018
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 06/04/2018
• 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