MAUDE Adverse Event Report: STRYKER TRAUMA KIEL REDUCTION SPOON T2 FEMUR 9 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
Customer reported that : "peroperative, during femoral nailing with the femoral nailing system 12, the distal part of the reduction nail broke at the junction with the thread in the medullary shaft.The extraction rod (1806-0110) coupled to the reduction instrument (1806-0125) can be used as a reduction instrument set.The crutched part of the reduction nail breaks without explanation at the junction with the screw thread: it is necessary to approach to remove it from the femoral shaft: lateral approach to expose the fracture, reduction after desincarceration and insertion of the guide pin." measures taken : technique modified, placement of an s.2 femur nail length 380, diameter 10 distal and proximal locking.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device as reported was received for evaluation but wasn¿t complete.Only the "spoon" (tip of the device) was returned which confirms the event.The device history record could not be reviewed because the affected device was returned but was incomplete i.E.Only "spoon" (tip of the device) was returned due to which it is not possible to confirm the lot.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿warnings and precautions: changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Do not hit instruments unless they are specifically intended for impaction.¿.More detailed information about the complaint event as well as the complete affected device must be available in order to determine the root cause of the complaint event.However, one of the probable causes of breakage could be user related i.E.Careless handling by hcp.If the complete device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
Customer reported that : "peroperative, during femoral nailing with the femoral nailing system 12, the distal part of the reduction nail broke at the junction with the thread in the medullary shaft.The extraction rod (1806-0110) coupled to the reduction instrument (1806-0125) can be used as a reduction instrument set.The crutched part of the reduction nail breaks without explanation at the junction with the screw thread: it is necessary to approach to remove it from the femoral shaft: lateral approach to expose the fracture, reduction after desincarceration and insertion of the guide pin.".Measures taken : technique modified, placement of an s.2 femur nail length 380, diameter 10 distal and proximal locking.

• Brand Name: REDUCTION SPOON T2 FEMUR 9 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: 10286363
• Report Number: 0009610622-2020-00326
• Device Sequence Number: 2678770
• Product Code: LXH
• UDI-Device Identifier: 04546540196040
• UDI-Public: 04546540196040
• 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): 10/21/2020

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: 1806-0125
• Device Catalogue Number: 18060125
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1