MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø11,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	0227-6110
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
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 during reaming, the instrument was damaged.It looked like the instrument was damaged by recoil when it hit a slightly hard bone.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: the visual inspection of the received device shows that the reamer is deformed approximately by 90 degrees from the middle and the coil has opened and is stretched from the middle due to this deformation.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.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to an improper usage of the reamer as it was operated in an anti-clockwise manner which is an off-label use.Consequently, the spiral at the middle of the of the reamer got wound up and bent.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that during reaming, the instrument was damaged.It looked like the instrument was damaged by recoil when it hit a slightly hard bone.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø11,0X480MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14826946
• Report Number: 0009610622-2022-00302
• Device Sequence Number: 4652749
• Product Code: MAY
• UDI-Device Identifier: 04546540145864
• UDI-Public: 04546540145864
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 0227-6110
• Device Catalogue Number: 02276110
• Device Lot Number: K0E99A7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female