MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DELTA STRIKE PLATE IMN INSTRUMENTS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	23510050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Laceration(s) (1946); Injury (2348)
Date of Event	08/28/2019
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.Device disposition unknown.
Event or Problem Description
As reported: "primary procedure to address a left femoral fracture with the t2 alpha gt nail.It was reported that on impaction, the strike plate broke at the junction with the insertion handle (the threads of the strike plate remained in the insertion handle).The strike plate hit the surgeon in the face, causing a small laceration (no stitches required).Case was completed by impacting directly on the insertion handle.Surgical delay was approximately 1 minute." the procedure was otherwise completed successfully.
Event or Problem Description
As reported: "primary procedure to address a left femoral fracture with the t2 alpha gt nail.It was reported that on impaction, the strike plate broke at the junction with the insertion handle (the threads of the strike plate remained in the insertion handle).The strike plate hit the surgeon in the face, causing a small laceration (no stitches required).Case was completed by impacting directly on the insertion handle.Surgical delay was approximately 1 minute." the procedure was otherwise completed successfully.
Additional Manufacturer Narrative
Device inspection of the delta strike plate in the imn instruments system confirmed that the threaded area of the device was broken.The device broke on the transition radii of the thread undercut to the stop shoulder of the thread connection.A microscopic analysis of the surface of the device shows a brittle area, which proves that the material was subjected to a significant amount of stress, which lead to its breakage without significant plastic deformation.The loads applied to the device damaged the strike plate.Furthermore, corrosive deposits were observed on the stop shoulder of the device.This is due to the repetitive rubbing between the delta strike plate and the targeting arm when the two are attached or detached from each other.The friction causes the protective layer of the delta strike plate to come off and for a thin layer of rust to deposit (most probably due to the cleaning and sterilization steps followed).A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.If any further information is provided, the investigation report will be updated.In order to avoid this kind of breakage in the future, an nc was opened to address this event.

• Brand Name: DELTA STRIKE PLATE IMN INSTRUMENTS
• 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: 9079074
• Report Number: 0009610622-2019-00698
• Device Sequence Number: 1573146
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/08/2019

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: 23510050
• Device Lot Number: KP423129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/11/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR