MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, AO FITTING BIXCUT Ø10,0X480 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	02256100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
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
Customer reported the: "intervention: left tibia nail.Problem with the reaming of the tibial shaft.The reamer has completely disintegrated and is broken at the base during reaming.Very high risk to the patient (31 years old).The material was trapped in the tibia on the reaming bar.Fortunately, we were able to remove the set without damaging the patient.".
Additional Manufacturer Narrative
The reported event could be confirmed.An inspection of the returned device revealed the following: the provided im reamer shaft of the bixcut system shows extensive signs of usage.The reamer adapter is broken in plastic manner due to torsional overload.The cutting edges of the bixcut head are marked with several dents and deformations, caused by hitting metal and multiple usage.The spiral winding of reamer at the proximal end is deformed; the spiral winding is broken at the crossing to the adapter.As per the reported event the product was trapped in the tibia on the reaming bar.To extract the reamer, the user rotated the reamer in an anti-clockwise direction but due to the jamming the spiral winding material got overloaded and deformed plastically (outer spiral winding became unraveled).Based on investigation performed, the root cause was attributed to a user related issue.The failure was caused by improper use of intramedullary reamer as it was used in a counter-clockwise direction causing it to become stuck inside the patient and in the process to remove, the extra load leading to its breakage.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.The instructions for use indicates the following: ¿never operate an intramedullary reamer in a counter-clockwise direction.Doing so causes the reamer shaft spiral to open and may lead to additional trauma.Always perform intramedullary reaming over a k-wire to prevent the reamer from drifting uncontrollably.Ensure that the drilling and cutting tools to be used are sharp; discard them if they are not.¿ if any further information is provided, the complaint report will be updated.
Event or Problem Description
Customer reported the: "intervention: left tibia nail.Problem with the reaming of the tibial shaft.The reamer has completely disintegrated and is broken at the base during reaming.Very high risk to the patient (31 years old).The material was trapped in the tibia on the reaming bar.Fortunately, we were able to remove the set without damaging the patient.".

• Brand Name: IM REAMER, AO FITTING BIXCUT Ø10,0X480 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9099401
• Report Number: 0009610622-2019-00728
• Device Sequence Number: 13979347
• Product Code: LXH
• UDI-Device Identifier: 04546540145376
• UDI-Public: 04546540145376
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 02256100
• Device Lot Number: K055D3F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 09/20/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1