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

Catalog Number	23510050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
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
T2 alpha impactor broke off in the spi tibia guide.Procedure was completed successfully with no adverse consequence or surgical delay reported.

• 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: 8927319
• Report Number: 0009610622-2019-00625
• Device Sequence Number: 16631290
• Product Code: LXH
• UDI-Device Identifier: 07613327350210
• UDI-Public: 07613327350210
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR