MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3 10.5X105MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 30600105S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 03/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"it was reported that the patient's left femur was revised due to the patient progressing to avascular necrosis.A gamma3 nail construct was revised to a total hip.".

Event Description

"it was reported that the patient's left femur was revised due to the patient progressing to avascular necrosis.A gamma3 nail construct was revised to a total hip.".

Manufacturer Narrative

The alleged event, necrosis, could not be confirmed because no medical records were provided.The product in question was not returned but received images revealed the affected item being undamaged after approx.1,5 years of implantation.Review of labelling, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No indications of design related problems were found during the document review.Avascular necrosis is known and nominated in the medical science / scientific literature.It is defined as the death of bone tissue due to a lack/ insufficient or interruption of the blood supply.Thus, the item is question is not linked to deficiency of the device but is related to the patient¿s condition.A product deficiency was not verified.In case essential information becomes available we reserve the right to re-reopen the case for investigation and to assess a new root cause.

• Brand Name: LAG SCREW, TI GAMMA3 10.5X105MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 11586343
• MDR Text Key: 243614544
• Report Number: 0009610622-2021-00433
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: K032244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

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: 30600105S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/29/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 91