MAUDE Adverse Event Report: STRYKER GMBH T2 FE RETRO NAIL LNG D10XL360; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	23391036S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
As reported: "nail broke at most distal proximal screw in alpha retro.Implanted in (b)(6)." according to additional information received the broken nail was removed and a larger diameter scn was implanted.It was further reported subsequently that pain showed that the nail had broken in clinic follow up.
Event or Problem Description
As reported: "nail broke at most distal proximal screw in alpha retro.Implanted in february." according to additional information received the broken nail was removed and a larger diameter scn was implanted.It was further reported subsequently that pain showed that the nail had broken in clinic follow up.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was 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 deficiencies.Potential causes for nail breakage are listed in the labelling.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were 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.

• Brand Name: T2 FE RETRO NAIL LNG D10XL360
• 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: 17907115
• Report Number: 0009610622-2023-00349
• Device Sequence Number: 7822901
• Product Code: HSB
• UDI-Device Identifier: 07613327292510
• UDI-Public: 07613327292510
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203819
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 23391036S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 26 YR
• Patient Sex: Male