MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-0300S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a patient who had undergone surgery about a year and a half ago was re-operated on after a postoperative pseudoarthrosis was identified.".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.Device discarded.
Event or Problem Description
As reported: "a patient who had undergone surgery about a year and a half ago was re-operated on after a postoperative pseudoarthrosis was identified.".
Additional Manufacturer Narrative
The reported event was not confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.A review of the rmf revealed no deficiency.The possibility of impaired bone healing is included in the documents.It was reported a patient experienced pseudoarthrosis after a year and a half requiring medical intervention.Implant damage or deficiency was not report and not present on provided x-ray.A product deficiency was not verified.Origin of the complaint is insufficient bone healing which was regarded as patient related.In case further substantive information becomes available we reserve the right to re-open the investigation and to re-assess a root cause.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X300MM 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13236661
• Report Number: 0009610622-2022-00015
• Device Sequence Number: 4709417
• Product Code: HSB
• UDI-Device Identifier: 04546540375711
• UDI-Public: 04546540375711
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 01/31/2025
• Device Model Number: 3525-0300S
• Device Catalogue Number: 35250300S
• Device Lot Number: K0281D9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/16/2021
• Supplement Date Received by Manufacturer: 04/21/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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: 53 YR
• Patient Sex: Male
• Patient Weight: 85 KG