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

Catalog Number UNK_KIE

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 10/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient's left femur was revised due to subsidence.Rep reported that the lag screw ripped through the femoral head.Patient was revised to a total hip construct.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.Implantation period of 1 year without event suggests correct implant placement but actually a typical cut out.

Event Description

It was reported that patient's left femur was revised due to subsidence.Rep reported that the lag screw ripped through the femoral head.Patient was revised to a total hip construct.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.Implantation period of 1 year without event suggests correct implant placement but actually a typical cut out.

Manufacturer Narrative

Event description did not report a product deficiency.Cutout is usually not caused by this product - thus concomitant item.

• Brand Name: UNKNOWN SHORT GAMMA NAIL
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8081161
• MDR Text Key: 127538699
• Report Number: 0009610622-2018-01403
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/16/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR