MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 0227-6110

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that during a gamma3 nail procedure, the bixcut reamer broke in the patient.All pieces were retrieved from the patient.The customer indicated that this device had been replaced in (b)(6) 2020.Update 05/05/2021: patient was being treated for primary, trochanteric hip fracture normal bone quality no images or x-rays are available.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text : device disposition is uknown.

Event Description

It was reported that during a gamma3 nail procedure, the bixcut reamer broke in the patient.All pieces were retrieved from the patient.The customer indicated that this device had been replaced in (b)(6) 2020.Update 05/05/2021: patient was being treated for primary, trochanteric hip fracture.Normal bone quality.No images or x-rays are available.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM
• 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
• MDR Report Key: 11824310
• MDR Text Key: 254614768
• Report Number: 0009610622-2021-00513
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 04546540145864
• UDI-Public: 04546540145864
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0227-6110
• Device Catalogue Number: 02276110
• Device Lot Number: K0E27C9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR