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

Catalog Number	02276080
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the tip of the 8 mm reamer shaft was damaged.".
Additional Manufacturer Narrative
The reported event could be confirmed since the physical examination revealed a broken im reamer, mod.Trinkle fitting bixcut 08,0x480mm.The device inspection revealed the following: the device in question presents a fully broken off reamer head.The broken off part was also returned.Flexible shaft shows slight bending in the first third of the flexible area of the reamer shaft as seen from the direction of the drill head.At the transition from the rigid to the flexible shaft area the reamer head was completely broken off.The adapter coupling for power tool presents clear signs of usage.The reamer head presents signs of damage.The inner surface has circumferential traces of evident ridge marks.Based on investigation, the root cause was attributed to a user related issue.The event was caused by improper handling during procedure.Utmost likely due to heavy contact by introduced k-wire during use of power tool in non-perfect form-fit the item slightly stuck and due to further use of rotary motion with power tool the head finally torn-off.Finally, the ifu also points out: ensure that bone debris does not accumulate in the cannulation of the instrument to reduce the risk of instrument binding on the k-wire.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.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.
Event or Problem Description
As reported: "the tip of the 8 mm reamer shaft was damaged".

• 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: 20766527
• Report Number: 0009610622-2024-00925
• Device Sequence Number: 13077531
• Product Code: MAY
• UDI-Device Identifier: 04546540145802
• UDI-Public: (01)04546540145802(10)K16EE2F
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 02276080
• Device Lot Number: K16EE2F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 11/23/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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 Age: 14 YR
• Patient Sex: Female
• Patient Weight: 80 KG