MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	0227-6080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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 by the customer that: "when doing a tibial nail the reamer metal started to unravel while it was in the patients tibia.Surgeon able to slap it out with no apparent harm to the patient.".
Event or Problem Description
It was reported by the customer that: "when doing a tibial nail the reamer metal started to unravel while it was in the patients tibia.Surgeon able to slap it out with no apparent harm to the patient.".
Additional Manufacturer Narrative
Correction - d3 (manufacturer entity), d9/h3, h3 (reason for no evaluation).The reported event could be confirmed, since one received image showed unraveled outer and inner spirals; at least the outer spiral was additionally broken off from the counterpart.The spiral was uncoiled in counterclockwise direction.Areas with reamer head resp with adapter connection were not shown.Spirals opened in counterclockwise direction had been operated in left-hand direction.The labeling prohibits turning to the left.If additional, substantive information or the item is provided the record will be reopened and the investigation will be re-assessed.The root cause was attributed as a user related issue.H3 other text : device disposition unknown.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 17241441
• Report Number: 0009610622-2023-00222
• Device Sequence Number: 12487271
• Product Code: MAY
• UDI-Device Identifier: 04546540145802
• UDI-Public: 04546540145802
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023

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: 0227-6080
• Device Catalogue Number: 02276080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown