MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING CALCANEAL PLATE CUTTER; INSTRUMENT,CUTTING,ORTHOPAEDIC

Model Number 329.151

Device Problems Crack (1135); Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the handles of a locking calcaneal plate cutter and small hexagonal screwdriver with holding sleeve were cracked and leave a brown stain after sterilization.There was no patient involvement.This report is for one (1) locking calcaneal plate cutter.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.A device history record (dhr) review was conducted: part: 329.151.Lot: 2490984.Manufacturing site: bettlach.Release to warehouse date: 08.June 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: the returned instrument was examined and there is no evidence of brown stain coming out of the handle.There is a crack on the handle of the device.The balance of the device is in worn condition.The received condition does agree with the complaint description.Document/specification review: relevant drawings for the returned device were reviewed (both current and from the time of manufacture): dimensional analysis: a dimensional inspection was not performed as the complaint is related to foreign substance and not any relevant feature on the instrument.There is no visual evidence or tangible evidence on the returned instrument that confirms the reported condition.Complaint has been confirmed for cracked handle it may have been contributed to the reported condition.Conclusion: a definitive root cause for the reported complaint condition could not be determined because the complaint could not be confirmed.It is possible fissures/splits/crack in the phenolic material which would create a cavity to retain fluid from use or reprocessing.It is possible that the specific sterilization procedure at the reporting hospital has contributed to the reported event and subsequent decontamination of the device at synthes monument site has removed all evidence of the reported condition.However, this cannot be definitively confirmed.During the investigation, no product design or manufacturing issues 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.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: LOCKING CALCANEAL PLATE CUTTER
• Type of Device: INSTRUMENT,CUTTING,ORTHOPAEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8414535
• MDR Text Key: 138771683
• Report Number: 2939274-2019-56932
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10886982191854
• UDI-Public: (01)10886982191854
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 329.151
• Device Catalogue Number: 329.151
• Device Lot Number: 2490984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Date Manufacturer Received: 04/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1