MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,5X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 0227-6105

Device Problems Break (1069); Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2022

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that im reamers broke during use.

Manufacturer Narrative

Correction : please refer to h6 clinical code, h6 health impact code.The reported event could be confirmed, since the device returned and matches the reported failure mode.The device inspection revealed the following: the im reamer was received in a dilapidated state with the spiral in an unwounded state at the proximal end with the adapter on verge of breaking out from the spiral.It is evident that the reamer was rotated in a counterclockwise direction.The spiral was also found to be broken at the distal where a cutting portion of the reamer is attached which looks to be a brittle fracture.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.Based on the investigation the root cause was attributed to a user related issue.The failure was caused due to improper usage of the reamer as it was operated in an anti-clockwise manner which is an off-label use if the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that im reamers broke during use.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø10,5X480MM
• Type of Device: 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: 15113555
• MDR Text Key: 302185843
• Report Number: 0009610622-2022-00344
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 04546540145857
• UDI-Public: 04546540145857
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0227-6105
• Device Catalogue Number: 02276105
• Device Lot Number: K0E1382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1