MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.037.257S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, the patient underwent an orthopedic procedure.The surgeon was operating a patient and was inserting a left femur nail, while inserting the helical blade, it was determined that the alignment was off.The nail and blade were removed and checked with the aiming arm and insertion handle on back table.It was determined that the insertion handle was bent.Another set was used to complete the surgery successfully.There was a surgical delay of ten (10) minutes.There was no patient consequence reported.This report involves one (1) tfna nail.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Therapy date: (b)(6) 2022.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h6: a device history record (dhr) review was conducted: manufacturing location: monument.Manufacturing date: 18-jan-2022.Expiration date: 31-dec-2031.Part number: 04.037.257s, 12mm/130 deg ti cann tfna 360mm/left- sterile.Lot number: 603p736 (sterile).Lot quantity:(b)(4).This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.H4.

• Brand Name: 12MM/130 DEG TI CANN TFNA 360MM/LEFT-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13928401
• Report Number: 2939274-2022-01086
• Device Sequence Number: 6251195
• Product Code: HSB
• UDI-Device Identifier: 10886982097378
• UDI-Public: (01)10886982097378
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: Health Professional
• Device Model Number: 04.037.257S
• Device Catalogue Number: 04.037.257S
• Device Lot Number: 603P736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2022
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130 DEG AIMING ARM; AIMING ARM LOCKING DEVICE; BLADE/SCREW GUIDE SLEEVE; BUTTRESS/COMPRESSION NUT; COMPLETE RADIOLUCENT INSERTION HANDLE; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE
• Patient Age: 58 YR
• Patient Sex: Female