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

Catalog Number	18060170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
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.
Event or Problem Description
It was reported that, during a primary procedure for a right hip, that the head of the mallet came off during use.Another mallet was immediately available in the o.R.And was used to complete the procedure successfully with no surgical delay.No adverse consequences reported.
Additional Manufacturer Narrative
Correction: sections d10 (concomitant medical products), h3 (device evaluated by mfr).The reported event could be confirmed, since the returned device matches with the alleged failure mode.The device inspection revealed the following: based on the visual inspection it can be concluded that the product has been very extensively used.The product shows several signs of dents damages and corrosion.However, it should be noted that the product is meant to be hammered and surface damage is not unusual for this product.Additionally, the connection between the hammer head and the handle appears to be severely damaged.The head and shaft broke at their brazing connection; the breakage surface indicates a fatigue fracture.Therefore, the hammer broke due to a high level of usages at the end of its life (normal wear).Due to the fact that this device was manufactured in 2011, and has more than 8 years of compliant performance, a material analysis was not deemed necessary, since if there were any material related issues, it would have been evident in the beginning of life of the device.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 event was not caused by a deficiency of the product; the root cause of the reported event is not device related, but is rather clearly linked to improper handling & normal wear over years of usage and repeated sterilization cycles.If any further information is provided, the investigation report will be updated.
Event or Problem Description
It was reported that, during a primary procedure for a right hip, that the head of the mallet came off during use.Another mallet was immediately available in the operating room and was used to complete the procedure successfully with no surgical delay.No adverse consequences reported.

• 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
• MDR Report Key: 8899051
• Report Number: 0009610622-2019-00611
• Device Sequence Number: 16823351
• Product Code: LXH
• UDI-Device Identifier: 04546540196118
• UDI-Public: 04546540196118
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/04/2019

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: 18060170
• Device Lot Number: K244907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR