MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TIBIAL NAIL, STANDARD T2 TIBIA Ø9X315 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1822-0931S
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the nail could not be removed and remained in the patient's body.A surgical delay of 30 minutes was reported.Update: the procedure was a planned removal due to bone healing.The event was not resolved.The nail could not be removed.At this time, the surgeon does not plan to make another attempt to extract the nail.".
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.
Event or Problem Description
As reported: "the nail could not be removed and remained in the patient's body.A surgical delay of 30 minutes was reported.Update: the procedure was a planned removal due to bone healing.The event was not resolved.The nail could not be removed.At this time, the surgeon does not plan to make another attempt to extract the nail.".
Additional Manufacturer Narrative
The alleged event was not confirmed.Although, the unit is allegedly still implanted; no evidence like medical records were provided.Review of dhr, labelling, capa databases and risk analysis did not identify any new discrepancies.There are no open actions in place related to the reported event for the subject product.It was reported: ¿the nail could not be removed and remained in the patient's body.¿.The procedure was a planned removal due to bone healing.The labelling points out ¿¿the x-ray ruler ¿ may be used to determine nail diameter and length¿.If the nail has been inserted too far, it has to be repositioned.¿ ¿ at a later stage it was confirmed that ¿the nail was too short and although it had been extended with end cap, the extractor could not be attached to the nail.¿ as the bone had healed the product had fulfilled its tasks as intended.With above information the cause of the event was regarded as not device related but rather user related.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø9X315 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13235315
• Report Number: 0009610622-2022-00011
• Device Sequence Number: 19894508
• Product Code: HSB
• UDI-Device Identifier: 04546540197764
• UDI-Public: 04546540197764
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2024
• Device Model Number: 1822-0931S
• Device Catalogue Number: 18220931S
• Device Lot Number: K087B82RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• 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
• Patient Sex: Male