MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 105MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.038.205S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
It was reported that on an unknown date, the patient had a lag screw in need of replacement with a short lag screw.It was found that the nail was broken at the level of the lag screw.The nail was removed and the nail, lag screw and locking screw were replaced.The procedure was successfully completed without surgical delay.There was no patient consequence.Concomitant device reported: unknown locking screw (part# unknown; lot# unknown; quantity: unknown).This report is for one (1) tfna fenestrated screw 105mm - sterile.This is report 2 of 2 for (b)(4).
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.H3, h4, h6: product complaint # (b)(4).Tfna fenestrated screw 105mm - sterile (part# 04.038.205s, lot# 14l8937, qty# 1) was returned and received at us cq.Upon visual inspection at cq, it is observed that the device shows severe nicks and some discoloration all over the body.These defects might have occurred during explantation procedure.The complaint cannot be confirmed for tfna fenestrated screw 105mm - sterile (part# 04.038.205s, lot# 14l8937).A definitive root cause could not be identified for the reported problem.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part # 04.038.205s.Synthes lot # 14l8937.Supplier lot # 14l8937.Release to warehouse date: 23 aug 2019.Expiration date: supplier: jabil-elmira.No ncr's were generated during production.Device history batch: null.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which 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.

• Brand Name: TFNA FENESTRATED SCREW 105MM - STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11304496
• Report Number: 2939274-2021-00739
• Device Sequence Number: 4830825
• Product Code: HSB
• UDI-Device Identifier: 10886982098795
• UDI-Public: 10886982098795
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 04.038.205S
• Device Catalogue Number: 04.038.205S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM/130 DEG TI CANN TFNA 380MM/LEFT - STERILE.; UNK - SCREWS: LOCKING.