MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIXA EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Model Number 03.835.004

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is jnj employee.Without a lot number, the device history records review could not be completed as no product was received.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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, the synfix evolution aiming device holder set sticks, will not attach easily to the aim devices.It was tested prior to a case and it was not working correctly.There was no patient involvement.Concomitant device reported.Unknown synfix evolution aiming device (par t# unknown, lot # unknown, qty unknown).This complaint involves one (1) device.This report is for (1) synfixâ® evolution aiming device holder.This report is 1 of 1 (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6: part 03.835.004, lot l094645: manufacturing site: hägendorf.Release to warehouse date: august 30, 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a photo investigation was completed: the images were reviewed based on the supplied images.The complaint condition of seized was unable to be confirmed as the images provided did not show any functionality issues.H3, h6: a product investigation was completed: the instrument was received and upon visual inspection no visual damage was noted.The functional test performed on the received device indicated that the outer shaft on the aiming device holder was stiff and very difficult to operate.Components in the device were not able to be separated.This is consistent with the reported complaint condition; the complaint was able to be replicated.Therefore, the complaint is confirmed.No dimensional inspection was performed as relevant dimensions could not be accessed without damaging the instrument.Based on the review of the relevant drawings, no design issues contributing to relevant complaint condition were identified.The complaint condition was confirmed for the instrument.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: SYNFIXA EVOLUTION AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11592307
• MDR Text Key: 243922931
• Report Number: 2939274-2021-01621
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10705034814100
• UDI-Public: 10705034814100
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 03/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 03.835.004
• Device Catalogue Number: 03.835.004
• Device Lot Number: L094645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 03/02/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/22/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN SYNFIX EVOLUTION AIMING DEVICE