MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 04.037.044S

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: the investigation could not be completed; no conclusion could be drawn, as no product was 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 Description

It was reported that on an unknown date, a damaged trochar and fns fell on the floor during an unknown procedure.There was no patient involvement.This report is for one (1) 10mm/130 deg ti cann tfna 235mm/right - sterile.This is report 1 of 1 for (b)(4).

Event Description

This is report 1 of 2 for (b)(4).

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.Manufacturing location: monument.Manufacturing date: 16-jul-2020.Expiration date: 31-may-2030.Part number: 04.037.044s, 10mm/130 deg ti cann tfna 235mm/right ¿ sterile.Lot number: 61p3013 (sterile).Lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final, met all inspection acceptance criteria.Inspection sheet, tfna assembly inspection, met all inspection acceptance criteria.Packaging label logs (pll) lppf were reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.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.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿implants fell on the floor¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.Visual inspection: the 10/130 deg ti cann tfna 235/right (part.No: 04.037.044s, lot.No: 61p3013, qty: 1) was returned and received at us customer quality (cq).Visual inspection of the complaint device showed no damage.Device failure/defect identified? no.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as no defects were identified with the complaint device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that 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 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: 10MM/130 DEG TI CANN TFNA 235MM/RIGHT - 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
• MDR Report Key: 12330820
• MDR Text Key: 266862608
• Report Number: 2939274-2021-04693
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096005
• UDI-Public: (01)10886982096005
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.044S
• Device Catalogue Number: 04.037.044S
• Device Lot Number: 61P3013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Date Manufacturer Received: 08/18/2021
• Patient Sequence Number: 1