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

Model Number 391.962

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Investigation summary: complaint summary: it was reported that on august 11, 2020, during an unknown procedure, the bending/ cutting pliers failed to open and cut an unknown mini fragment plate.As per the reporter, there was a missing tooth.The procedure was completed successfully using an alternative unknown cutting device.There was no surgical delay reported.There was no issue with the patient.The instrument(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition for failed to open and cut and missing tooth could not be confirmed as the image provided does not show the threads or functionality of the device.As the instrument(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) 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 history lot: part number: 391.962.Lot number: t948933.Manufacturing site: (b)(4).Release to warehouse date: july 21, 2010 a review of the device history records was performed for the finished device lot number, and no non-conformances were identified.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) 2020, during an unknown procedure, the bending/ cutting pliers failed to open and cut an unknown mini fragment plate.As per the reporter, there was a missing tooth.The procedure was completed successfully using an alternative unknown cutting device.There was no surgical delay reported.There was no patient consequence.Concomitant device reported: unknown mini fragment plate (part# unknown, lot# unknown, quantity 1) this report is for one (1) bending/cutting pliers.This is report 1 of 1 for (b)(4).

• Brand Name: BENDING/CUTTING PLIERS
• Type of Device: PLIERS,SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10502008
• MDR Text Key: 207000781
• Report Number: 2939274-2020-04009
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 10886982198525
• UDI-Public: (01)10886982198525
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 391.962
• Device Catalogue Number: 391.962
• Device Lot Number: T948933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR