MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL, STANDARD T2 TIBIA Ø11X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18221136S
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2024
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
The sales rep reported that: "during the operation, the surgical team was unable to complete the procedure due to a technical problem with the ancillary parts.After reaming the patient's tibia and identifying the implant to be placed, the operators were unable to continue the procedure due to a problem with the assembly and disassembly of the bolt, nail holder and implant.The bolt and nail holder remained attached, making it impossible to dismantle the implant once the procedure had been completed.For safety reasons, the operators preferred not to implant the implant and to postpone the operation to a later date.Intervention postponed to 07/31 instead of 07/27.The operation was carried out by an experienced surgical team.The ¿recovery¿ operation took place in the presence of the local sales manager, and went smoothly.The faulty equipment was taken back by the sales representative for expert examination.".
Event or Problem Description
The sales rep reported that: "during the operation, the surgical team was unable to complete the procedure due to a technical problem with the ancillary parts.After reaming the patient's tibia and identifying the implant to be placed, the operators were unable to continue the procedure due to a problem with the assembly and disassembly of the bolt, nail holder and implant.The bolt and nail holder remained attached, making it impossible to dismantle the implant once the procedure had been completed.For safety reasons, the operators preferred not to implant the implant and to postpone the operation to a later date.Intervention postponed to on (b)(6) instead of on (b)(6).The operation was carried out by an experienced surgical team.The ¿recovery¿ operation took place in the presence of the local sales manager and went smoothly.The faulty equipment was taken back by the sales representative for expert examination.".
Additional Manufacturer Narrative
Corrections: please refer to d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø11X360 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20039563
• Report Number: 0009610622-2024-00807
• Device Sequence Number: 12396291
• Product Code: HSB
• UDI-Device Identifier: 04546540198051
• UDI-Public: 04546540198051
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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: Health Professional
• Device Catalogue Number: 18221136S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male