MAUDE Adverse Event Report: STRYKER TRAUMA KIEL EXTRACTION HOOK, SMALL IMPLANT EXTRACTION SET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18066160
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/22/2018
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
After the proximal broken nail and lag screw were removed, extraction hook (18066160) was hanged to the distal part of nail and hit with hammer and about 1mm of the tip of the extraction hook was lacked and the it was not able to be hanged to nail.Therefore, new hook was used, but the tip of the hook was bent after it was hit with hammer and not able to be used.Therefore, the distal part of the nail and broken hook was left in the patient body and operation was finished.Removal of nail remained in the patient's body was done.However, the distal part of the nail was not removed and it was left and chs implant (synthes) was deployed.Revision # 2 reported under separate pi.

• Brand Name: EXTRACTION HOOK, SMALL IMPLANT EXTRACTION SET
• 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: 8081169
• Report Number: 0009610622-2018-01405
• Device Sequence Number: 2879012
• Product Code: LXH
• UDI-Device Identifier: 04546540509994
• UDI-Public: 04546540509994
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

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: 18066160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR
• Patient Weight: 56