MAUDE Adverse Event Report: STRYKER TRAUMA KIEL STRIKE PLATE T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0150
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
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
It was reported that the surgeon hit the strike plate attached to the targeting arm and as he did so the strike plate threads broke inside the targeting arm.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation.And matches the alleged failure mode.The device inspection revealed, the following: physical examination of the returned device showed, the strike plate to be broken at the threaded part.The breakage pattern has the characteristic, that a chunk of the material between two levels of threads has been chopped off creating a missing "window" of material.Under microscope, it can clearly be seen that the surface below the connected threads presents a crack.The device was manufactured in 2002, so it can be said, that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity, due to repeated reprocessing cycles is considered possible.The analysis of the material at the surface of the broken threads shows multiple secondary fractures (cracks in the material).Which are most probably, due to the fatigue of the material under bending stresses.This could have induced pre-damage to the material.Which would have finally gave in, because of torsional overload.Impact marks are also visible on the surface of proximal part of strike plate.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 material, manufacturing or design related problems were found, during the investigation.A review of the labeling did not indicate, any abnormalities.The instructions for use instructs user that: ¿do not hit instruments unless, they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate! always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.The stryker instructions for cleaning: sterilization, inspection and maintenance help to determine whether an instrument is in good condition or must be replaced, due to excessive wear or obvious defects.Before the surgical procedure, ensure that all components prepared for the procedure function correctly with each other.During the procedure, repeatedly check that the connections between the instruments or between implants.And instruments required for the precise positioning and fixing are secure¿.Based on investigation, the root cause was attributed to a normal wear related issue.The device was manufactured in 2002, so it can be said, that it has performed its function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity, due to repeated reprocessing cycles is considered possible.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported, that the surgeon hit the strike plate attached to the targeting arm.And as he did so, the strike plate threads broke inside the targeting arm.

• Brand Name: STRIKE PLATE T2 FEMUR
• 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: 11278327
• Report Number: 0009610622-2021-00257
• Device Sequence Number: 14100753
• Product Code: LXH
• UDI-Device Identifier: 04546540196088
• UDI-Public: 04546540196088
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 1806-0150
• Device Catalogue Number: 18060150
• Device Lot Number: K469133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1