MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S; SCREW,FIXATION,BONE

Model Number	04.005.526S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # :(b)(4).Event year is reported as 2021; however exact date of event is unknown.Additional product code: hwc complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on unknown date, the patient underwent for a revision surgery.During the surgery, the surgeon replaced a new tfn, helical blade and locking screw.Due to lose of helical blade inside the nail, which was causing the cut out.It was unknown if the revision surgery completed successfully.There were no patient consequences are reported.Concomitant device reported: 170mm titanium cannulated trochanteric fixation nail: (part# 456.318s; lot# unknown; quantity: 1) locking screw 5.0mm (part# 04.005.526s; lot# unknown; quantity: 1) this complaint involves three (3) devices.This report is for (1)5.0 ti lckng screw t25 sd 36 f/im nail-s this report is 3 of 3 for (b)(4).

• Brand Name: 5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12173676
• Report Number: 2939274-2021-04110
• Device Sequence Number: 16383968
• Product Code: HWC
• UDI-Device Identifier: 10886982085955
• UDI-Public: (01)10886982085955
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: Health Professional
• Device Model Number: 04.005.526S
• Device Catalogue Number: 04.005.526S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11.0MM TI HELICAL BLADE 105MM-STERILE; 5.0 TI LCKNG SCREW T25 SD 36 F/IM NAIL-S
• Outcome Attributed to Adverse Event: Required Intervention