MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTING PLIERS; PLIERS,SURGICAL

Catalog Number 391.931

Device Problems Break (1069); Crack (1135); Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reportability changed based on investigation result.Deemed reportable august 2, 2019.Original alert date june 6, 2019.Investigation summary: the cutting pliers (part # 391.931, lot # 1003) was received at us cq.The cutting edged appeared in good shape however the adjacent cushions were both damaged.One of the cushions had a crack, and the other cushion had a significant piece of it broken off.There are light scratches along the body of the device that is consistent with wear.The received condition is consistent with the complaint condition thus the complaint is confirmed.Dimensional inspection: due to the age of the device (16yrs) and a lack of relevant information on the source control drawing, a dimensional inspection was not performed.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) no issues.Manufacturing record evaluation: the cutting pliers (part # 391.931, lot # 1003) was manufactured at the (b)(6) site on 02-apr-2003.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Conclusion: the complaint was confirmed for the cutting pliers (part # 391.931, lot # 1003).The device was returned with one of the cushions broken and the other cracked.There were light cosmetic issues along the body that is consistent with normal wear.Although no definite root cause could be determined, it is possible that the device experienced unintended forces during use over its lifecycle.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 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 history review: part 391.931.Lot 1003.Manufacturing site: (b)(6).Manufacturing date: 02.Apr.2003.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that 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.

Event Description

It was reported that on (b)(6) 2019, during a routine inspection at the sterile processing department, the cutting edges of the variable angle locking compression plate bending plier were damaged.There was no patient involvement.This is report 1 of 1 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.Due to the age of the device (16yrs) and a lack of relevant information on the source control drawing, a dimensional inspection was not performed.The cutting pliers (part # 391.931 lot # 1003) was manufactured at the haegendorf site on 02-apr-2003.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The complaint was confirmed for the cutting pliers (part # 391.931 lot # 1003).The device was returned with one of the cushions broken and the other cracked.There were light cosmetic issues along the body that is consistent with normal wear.Although no definite root cause could be determined, it is possible that the device experienced unintended forces during use over its lifecycle.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 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 history lot.Dhr review for p/n 391.931, lot 1003, manufacturing site: haegendorf, manufacturing date: 02.Apr.2003.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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.

Event Description

It was reported that on (b)(6) 2019, during a routine inspection at the sterile processing department, the cutting edges of the cutting pliers were damaged.

• Brand Name: CUTTING PLIERS
• Type of Device: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8861315
• MDR Text Key: 153366965
• Report Number: 2939274-2019-59531
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982198464
• UDI-Public: (01)10886982198464
• 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: 06/06/2019

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 Catalogue Number: 391.931
• Device Lot Number: 1003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 08/05/2019
• Supplement Dates FDA Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1