MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT 11,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0225-6110
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported that, "during the reaming of the tibial shaft with the engine, by taking out reamer number 11 ,the distal part of it came off of the stem and remained in the tibial shaft of the patient.Fortunately, the guide rod the buttons we used allowed us to extract it without worry.".
Additional Manufacturer Narrative
Correction: sections d4 lot number and h6 device code.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the im reamer was received in a dilapidated state with the cutting bit at the distal end completely detached from the spiral.Spiral and the cutting edges, overall, looked in alright state.However, the point of detachment shows signs of excessive rotation and slight burn mark due to generated heat during use.The manner of detachment and deformation indicates towards forced usage of the reamer.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause of the failure was determined to be user related.It¿s a case of a forced breakage of the reamer under excessive rotational force using a power tool as evident by the returned device.Through the additional information received, it was discovered that the power tool used does not belong to stryker and hence this usage is deemed as an off-label use.The instruction for use clearly suggests the user that: ¿do not use components of stryker product systems together with components from any other manufacturer unless specified otherwise in the operative technique.¿ if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reported that : "during the reaming of the tibial shaft with the engine, by taking out reamer number 11 ,the distal part of it came off of the stem and remained in the tibial shaft of the patient.Fortunately, the guide rod the buttons we used allowed us to extract it without worry.".

• Brand Name: IM REAMER, AO FITTING BIXCUT 11,0X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10972531
• Report Number: 0009610622-2020-00906
• Device Sequence Number: 14535455
• Product Code: LXH
• UDI-Device Identifier: 04546540145390
• UDI-Public: 04546540145390
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: 0225-6110
• Device Catalogue Number: 02256110
• Device Lot Number: K040D1C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1