MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PROACCESS(TM) VERTICAL MAST; RETRACTOR

Catalog Number 03.612.001

Device Problem Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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 pro access vertical mast began to loosen.An unknown support for the retractors had to be constantly tightened so the device could be used properly.The issue was observed before the onset of the procedure.There was no patient involvement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

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.Device history record (dhr) review: part: 03.612.001; lot: 1407959; manufacturing site: haegendorf; release to warehouse date: 14.Nov.2005.The device history record shows this lot of 60 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: investigation summary: it was reported that a proaccess vertical mast was noticed to be coming loose and that a support for retractors had to be constantly tighten so that it can be used properly.The issue was observed before the onset of the procedure.Device interaction/functional flow: visual inspection: upon visual inspection a crack was noticed on the returned mast¿s clamp sleeve.Additionally, the mast exhibited various superficial damage, including deformations on its shaft cap, and an ¿e¿ etched on the mast clamp, indicating that the mast was most likely part of an evaluations set.Functional test: a part that would mate with the mast coupling was not available so a functional test could not be performed.Does the received condition agree with the complaint description? yes.The crack noticed on the mast¿s clamp sleeve would prevent it from holding mating parts as intended.Can the complaint be replicated with the returned device(s)? a part that would mate with the mast coupling was not available so a functional test could not be performed.Dimensional inspection: since the cracked sleeve was housed in the coupling no relevant dimensional testing could be performed.Document/specification review: relevant drawings were reviewed and no product design issues or discrepancies were observed.Was the complaint confirmed? yes.The crack noticed on the mast¿s clamp sleeve would prevent it from holding mating parts as intended.Investigation conclusion: although a definitive root cause could not be determined for the complaint condition, the returned mast is over 12 years old, and it is most likely that the complaint condition occurred due to the cumulative effect of frequent routine use during its lifespan.It was also most likely that the mast was part of an evaluations set, which would increase the amount of times it would be transported, and potentially be exposed to unintended forces.The superficial damage noticed on the coupling, including the deformation on the shaft cap indicate that the coupling could have been manipulated in an unintended manner, which could have contributed to the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: PROACCESS(TM) VERTICAL MAST
• Type of Device: RETRACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7869989
• MDR Text Key: 120101760
• Report Number: 2939274-2018-53742
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 10705034714462
• UDI-Public: (01)10705034714462
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.612.001
• Device Lot Number: 1407959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1