MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18220936S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
Rep was informed about case: broken t2 tibia on (b)(6) 2019 after placement on (b)(6) 2018.The patient has received the t2 tibia 9mm pen at the (b)(6) and yesterday was urgently operated at the (b)(6) in (b)(6) and the nail was removed.Rep contacted with two trauma surgeons who have both been surprised about the breaking of the pen.Data is now being requested and the nail is in possession of surgeon.
Event or Problem Description
Rep was informed about case: broken t2 tibia on (b)(6) 2019 after placement on (b)(6) 2018.The patient has received the t2 tibia 9mm pen at (b)(6) and yesterday was urgently operated at (b)(6) and the nail was removed.Rep contacted with two trauma surgeons who have both been surprised about the breaking of the pen.Data is now being requested and the nail is in possession of surgeon.
Additional Manufacturer Narrative
The returned device matched the report, and the complaint failure mode was confirmed.The review of manufacturing documents revealed no deviation in material or in the manufacturing process.The review of the risk assessment indicated the issue was within tolerance, therefore no corrective actions are deemed necessary at this time.The nail broke after an implantation period of approx.2 weeks.According to the breakage pattern, smooth surface (where undamaged), significant deformed areas (with material ¿rubbed shiny¿), a secondary crack and additional nail bending in m-l-direction at the level of the bone fracture lead to the conclusion that the nail broke at an early stage in a sudden manner.The difference of the distal and proximal breakage surfaces is explained by missing contact to each other after nail breakage.The proximal nail fragment had rather contact to the (not returned) locking screw which would show similar material damages if available.It could not be determined whether the observed scratches in the affected drill hole had been caused intra-operatively by a deflected drill or by the threads of the corresponding screw.It could also not be determined if the scratches had originated to an initial crack.Since no operation reports were provided it could not be determined if the patient had followed the surgeon¿s post-op instructions regarding weight bearing; neither was the patient¿s weight provided.Potential adverse effects are listed in the ifu.Pre-, intra- and post-operative instructions are included.In this case the nail broke in a sudden manner caused by significant and sudden overload leading to early nail breakage including unintended axial bending of the nail.Above was regarded as patient related/contributed by the user.In case relevant information regarding the device becomes available, the investigation and root cause will be updated accordingly.With available information a deficiency of the nail was not verified.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X360 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: 8287408
• Report Number: 0009610622-2019-00060
• Device Sequence Number: 19330581
• Product Code: HSB
• UDI-Device Identifier: 04546540197795
• UDI-Public: 04546540197795
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 18220936S
• Device Lot Number: K0B9141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/24/2019
• 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
• Patient Age: 43 YR