MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø11X340 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18431134S
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Remains in the patient.
Event or Problem Description
It was reported that secondary fracture occurred around the distal lateral screw of t2 nail on (b)(6) 2018.During rehabilitation, complained a pain around the knee although continued rehabilitation.Then visited a hospital and found a secondary fracture in the nail distal."it will" revision surgery on (b)(6) 2019.
Additional Manufacturer Narrative
The reported event that the secondary fracture occurred around the distal lateral screw of t2 nail could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.As the product was not returned, it could not be determined in what way the nail had broken nor if the nail had been damaged intra-operatively.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history, some of the possible causes of this one requirement for successful nail treatment is a timely bone healing in order to relive the implants over the progressing time of implantation.Another requirement is that the implant must not be damaged during and after insertion.Surface damages reduce the implant¿s durability significantly.A third requirement is that the implant must not be stressed by too high load application e.G.(but not limited to) exceeding weight bearing or overweight or other stresses.In this case implant breakage had occurred after an implantation period of approx.4 months.It could not be determined if the patient had been compliant to the surgeon¿s instruction regarding post-operative load bearing.Based on the given information a deficiency of the nail could not be verified.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
It was reported that secondary fracture occurred around the distal lateral screw of t2 nail on (b)(6) 2018.During rehabilitation, complained a pain around the knee although continued rehabilitation.Then visited a hospital and found a secondary fracture in the nail distal.It will revision surgery on (b)(6) 2019.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON Ø11X340 MM X 125°
• 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: 8374915
• Report Number: 0009610622-2019-00082
• Device Sequence Number: 2203182
• Product Code: HSB
• UDI-Device Identifier: 04546540383839
• UDI-Public: 04546540383839
• Combination Product (Y/N): N
• PMA/510(K) Number: K102992
• 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,Followup
• Report Date (Section B): 04/02/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 18431134S
• Device Lot Number: K0D53CC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/14/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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