MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø6.0X400MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Catalog Number	02275060
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device tip remains in patient.
Event or Problem Description
The reamer was broken during re-revision of tha and tip part of the reamer was left in the patient's femur on (b)(6) 2023 (note: this record was opened for broken reamer and another pi was opened for re-revision).After removing cement to some extent, reaming was performed using 6mm flexible reamer.However, tip of the reamer got stuck with cement in the medullary cavity of a bone.The surgeon tried to remove the reamer by reaming again and again, but the shaft of the reamer was broken and tip part of the reamer was left in the cement.Because the surgery took a very long time, the surgeon decided that the femoral implant would be removed at a later date, and the surgery was finished while the tip part of the broken reamer still in the patient's body.The surgeon told that about a month later, when the patient is ready for surgery, he will perform the surgery again and treat the femoral side.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø6.0X400MM
• 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: 17850594
• Report Number: 0009610622-2023-00341
• Device Sequence Number: 14316096
• Product Code: MAY
• UDI-Device Identifier: 04546540145765
• UDI-Public: 04546540145765
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123604
• 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
• Report Date (Section B): 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02275060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 10/02/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown