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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
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
As reported, "the connecting thread between 2351-0050 and 2351-0180 is broken.".
Event or Problem Description
As reported: "the connecting thread between 2351-0050 and 2351-0180 is broken.".
Additional Manufacturer Narrative
The reported event was confirmed.The device returned broke on the transition radii of the thread undercut to the stop shoulder of the thread connection.The macroscopic appearance of the breakage surface revealed a forced fracture in brittle manner.Plastic deformation was not apparent.The material had been subjected to a significant amount of stresses, which lead to a breakage without significant plastic deformation.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 ongoing investigation regarding the delta strike plates.If any further information is provided, the investigation report will be updated.

• 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; GM D-24232
• MDR Report Key: 10896153
• Report Number: 0009610622-2020-00773
• Device Sequence Number: 16895575
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/17/2021

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: 2351-0050
• Device Catalogue Number: 23510050
• Device Lot Number: KP423129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 02/17/2021
• 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