MAUDE Adverse Event Report: STRYKER TRAUMA KIEL SLOTTED HAMMER T2 FEMUR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-0170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
Mallet head disassociated with handle.
Event or Problem Description
Mallet head disassociated with handle.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.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.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, the breakage of the welding seam may occur, when too strong forces, more forces than need to insert or extract a t2 femur nail, are applied on the device.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: SLOTTED HAMMER 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: 11068974
• Report Number: 0009610622-2020-01043
• Device Sequence Number: 3207199
• Product Code: LXH
• UDI-Device Identifier: 04546540196118
• UDI-Public: 04546540196118
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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: 1806-0170
• Device Catalogue Number: 18060170
• Device Lot Number: K741594
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/29/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1