MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT 8,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	0225-6080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
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 : "(b)(6) patient, undergoing osteosynthesis surgery by a shin nail on the left following a fracture of the left leg.The reamer has broken during the reaming of the left tibial shaft of the patient.The broken piece was recovered.The reamer was put into operation on 17/08/2016 and sterilized 358 times.Clinical consequences and current status of the patient or person involved: lengthening of the operating time.Risk of loss of an element in the tibial shaft.".
Event or Problem Description
The customer reported that: "19-year-old patient, undergoing osteosynthesis surgery by a shin nail on the left following a fracture of the left leg.The reamer has broken during the reaming of the left tibial shaft of the patient.The broken piece was recovered.The reamer was put into operation on (b)(6) 2016 and sterilized 358 times.Clinical consequences and current status of the patient or person involved: lengthening of the operating time.Risk of loss of an element in the tibial shaft.".
Additional Manufacturer Narrative
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 with its reamer head detached from the spiral.Spiral overall looked in an alright state.However, the point of detachment shows signs of excessive rotation and slight burn mark due to generated heat during use.The adapter necked from the breaking point.This manner of detachment and deformation indicates towards torsional overload.The reamer head shaft diameter of the was observed to be 6.48mm against the required diameter in the range of 6.40mm to 6.60mm.Similarly, the average hardness of the drill was observed to be 47.4 hrc against the required hardness in the range of 46.0hrc to 50.0hrc.As per the dimensional inspection and hardness testing, the returned reamer was found to be within specifications.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 due to torsional overload.The reason for the torsion overloads could not be determined but most likely the reamer bixcut heads got stuck in the marrow channel during reaming.The operative technique includes that reaming should be done in 0.5mm increments until cortical contact is appreciated.If any additional information is provided, the investigation will be reassessed.

• Brand Name: IM REAMER, AO FITTING BIXCUT 8,0X480 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: 11413218
• Report Number: 0009610622-2021-00319
• Device Sequence Number: 17130404
• Product Code: LXH
• UDI-Device Identifier: 04546540145338
• UDI-Public: 04546540145338
• 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): 04/12/2021

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: 0225-6080
• Device Catalogue Number: 02256080
• Device Lot Number: K0794F3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR