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

Model Number	2351-0050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the thread broke.
Event or Problem Description
It was reported that the thread broke.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the device inspection shows that the threaded area is broken.The returned device broke at the transition radii of the thread undercut to the stop shoulder of the thread connection.A microscope analysis of the surface of the device shows a brittle area, which proves that the material was subjected to a massive amount of stress, which led to its breakage without significant plastic deformation.Review of the device history records revealed no deviation from the specification.The inspection protocol was reviewed.Functionality test and dimensional inspection were done according to specifications.However, investigation revealed the root cause of the reported event to be a design-related issue.A non-conformity report has led to further investigation and finally to a recall; the returned device is in the scope of the pfa (b)(4) ongoing on the delta strike plates.

• 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; DE D-24232
• MDR Report Key: 9586874
• Report Number: 0009610622-2020-00016
• Device Sequence Number: 3389198
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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: 2351-0050
• Device Catalogue Number: 23510050
• Device Lot Number: KP423129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 8031020-11-27-2019-004R
• Patient Sequence Number: 1