MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	02276075
Medical Device Problem Codes	Dent in Material (2526); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
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
The handpiece rotation was reversed during diaphyseal reaming.Bixcut was damaged because the operation was carried out without realizing it.Debris remained in the body, but was removed using pliers and a hammer.After confirming that no debris remained in the body, nail fixation was performed and the operation was completed.
Event or Problem Description
The handpiece rotation was reversed during diaphyseal reaming.Bixcut was damaged because the operation was carried out without realizing it.Debris remained in the body, but was removed using pliers and a hammer.After confirming that no debris remained in the body, nail fixation was performed and the operation was completed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches with the alleged failure.The received bixcut reamer was found slightly bent (approx.In middle) with dent marks.The outer spiral of the reamer is completely uncoiled and deformed.The breakage areas of reamer spirals indicate that the spirals broke in a gliding fracture due to torsional overload; the reamer was overloaded in counter-clockwise direction.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to reamer was used in a counter-clockwise direction.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.The device had been in use for a long time (manufactured in 2014), therefore it can be safely said that it had fulfilled its tasks in former surgeries as intended.A review of the labeling did not indicate any abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø7,5X480MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9262918
• Report Number: 0009610622-2019-00912
• Device Sequence Number: 2777486
• Product Code: LPH
• UDI-Device Identifier: 04546540145796
• UDI-Public: 04546540145796
• Combination Product (Y/N): N
• PMA/510(K) Number: K153345
• 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): 12/30/2019

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: 02276075
• Device Lot Number: K09F7F3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR