MAUDE Adverse Event Report: STRYKER TRAUMA KIEL UNKNOWN GAMMA3 NAIL; IMPLANT

Catalog Number UNK_KIE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available it will be provided on a supplemental report.

Event Description

It was reported that patient's right hip was revised.As reported by rep: "lag screw cut out of the femoral head therefore needed to be removed and revised." confirmed with rep on the phone (b)(6) 2017 that explanted components were a gamma 3 nail, lag screw, and a locking screw.Revised to a total hip.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

Manufacturer Narrative

Event description does not refer to a product deficiency.A gamma nail screw does not contribute to cut out.Thus, concomitant item.

Event Description

It was reported that patient's right hip was revised.As reported by rep: "lag screw cut out of the femoral head therefore needed to be removed and revised." confirmed with rep on the phone (b)(6) 2017 that explanted components were a gamma 3 nail, lag screw, and a locking screw.Revised to a total hip.Rep reported that x-rays, medical records, and further information are not available due to hospital policy.

• Brand Name: UNKNOWN GAMMA3 NAIL
• Type of Device: IMPLANT
• 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: 6976437
• MDR Text Key: 90211308
• Report Number: 0009610622-2017-00341
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_KIE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR