MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL T2 ALPHA TIBIA 12X255MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	2341-1225S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
As reported: oblique fracture of the distal 1/3 of the tibia.Perform flexible reaming up to f13 and insert f12 × 255 mm nails.At the time of nail insertion, the central bone fragment was displaced anteriorly at the fractured part, so a blocking k wire was inserted, but after repositioning, it was inserted again, but anterior dislocation again.The posterior part of the fracture was greatly crushed, and the doctor decided that the t2 alpha tibial nail could not maintain the reduction position, so it was changed to external fixation.Doctor's comment: the shape of the nail did not match the shape of the patient's bone.The bone quality was too weak.The plate will be fixed at a later date.
Additional Manufacturer Narrative
The alleged event was not confirmed.Product and / or medical records were not provided.A review of dhr, nc history, labelling and rmf revealed no deficiency.According to documentation the item was distributed according to specs.The labelling provides information how to determine the nail size.According to received information (¿the shape of the nail did not match the shape of the patient's bone.The bone quality was too weak¿) the alleged event was classified having been caused by a suboptimal implant selection and was regarded being user related.In case other essential information becomes available were reserve the right to re-reopen the case for investigation and to assess a new root cause.With available information a deficiency of the device could not be verified.
Event or Problem Description
As reported: oblique fracture of the distal 1/3 of the tibia.Perform flexible reaming up to f13 and insert f12 × 255 mm nails.At the time of nail insertion, the central bone fragment was displaced anteriorly at the fractured part, so a blocking k wire was inserted, but after repositioning, it was inserted again, but anterior dislocation again.The posterior part of the fracture was greatly crushed, and the doctor decided that the t2 alpha tibial nail could not maintain the reduction position, so it was changed to external fixation.Doctor's comment: the shape of the nail did not match the shape of the patient's bone.The bone quality was too weak.The plate will be fixed at a later date.

• Brand Name: TIBIAL NAIL T2 ALPHA TIBIA 12X255MM
• Common Device Name: 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: 10953268
• Report Number: 0009610622-2020-00830
• Device Sequence Number: 14257290
• Product Code: HSB
• UDI-Device Identifier: 07613327291063
• UDI-Public: 07613327291063
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K191271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 2341-1225S
• Device Catalogue Number: 23411225S
• Device Lot Number: K0837BC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 02/17/2021
• 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: Other
• Patient Age: 80 YR