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

Catalog Number 18066160

Device Problems Break (1069); Entrapment of Device (1212); Device Damaged by Another Device (2915); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event 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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8081169
• MDR Text Key: 128044206
• Report Number: 0009610622-2018-01405
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540509994
• UDI-Public: 04546540509994
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 18066160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 56