MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5 TI RECON SCREW T25 SD 85-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.003.027S

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Date 06/09/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, the removal of broken nail due to nonunion.The surgery was successfully completed with no delay.No fragments were generated.There is no further information.This report is for one (1)6.5 ti recon screw t25 sd 85-sterile.This is report 5 of 5 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6.5 TI RECON SCREW T25 SD 85-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester 19380 ; 3035526892
• MDR Report Key: 14950276
• MDR Text Key: 295474130
• Report Number: 2939274-2022-02508
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982081582
• UDI-Public: (01)10886982081582
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.003.027S
• Device Catalogue Number: 04.003.027S
• Device Lot Number: 38P7372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female