MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18965037S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could be confirmed, although the device was not returned but an x-ray was provided which confirms the breakage.A device inspection was not possible since the affected device was not returned, and only an x-ray was provided for investigation.The medical expert opinion revealed the following: ¿there has been osteoporotic or osteopenic surrounding bone can hardly be assessed via x-ray.If there is no preoperative information.The initial positioning of the nail and the screws seems to be alright.It is again a little hard to say as we do only have the two x-rays showing the situation after loosening of the nail.As there is no union visible on the x-ray so far.We have a case of non-union, here.We have very clear signs of loosening with at the distal tibia and calcaneus.The other measurements taken to support the union seem reasonable and are according to the state-of-the-art, but unfortunately failures can still occur.¿ based on the above investigation most probably the failure was due to the patient¿s condition (nonunion) but due to insufficient information and product not returned for evaluation the exact root cause could not be determined.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The following event was reported by the end user to the (b)(6) competent authority ((b)(6)); breakage of the locking screws.Revision surgery on (b)(6) 2019.

• Brand Name: LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X37,5 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 9567050
• Report Number: 0009610622-2020-00007
• Device Sequence Number: 14034903
• Product Code: HSB
• UDI-Device Identifier: 04546540382337
• UDI-Public: 04546540382337
• Combination Product (Y/N): N
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 18965037S
• Device Lot Number: K0B39A1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 01/08/2020
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 66