MAUDE Adverse Event Report: SYNTHES GMBH PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL; PLIERS, SURGICAL

Catalog Number 03.130.270

Device Problem Break (1069)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: only event year is known.The device has been 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the jaw of the pliers broke during the operation.There were no reported patient consequences.This report involves one (1) plate cutter/in-line for 1.3mm lckng/1.5-2.0mm val pl.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the inspection has shown that the cutting head of the lower jaw is broken off.The fragment was returned for evaluation.The inspection has also shown that there are some strong impression marks on the plate holding surfaces and that the rounded cutting edges have burrs and are therefore blunt.Dimensional inspection: the relevant dimensions cannot be verified anymore as the breakage occurred at the crossover form the handle to the head.Document specification review: relevant drawing was reviewed to verify the hardness specification.Relative drawing was reviewed to verify the material specification of the lower jaw.The review of the manufacturing documents has shown that the hardness was within the specification and the used material was stainless steel as required.Investigation conclusion: the complaint is rated as confirmed as the cutting head of the lower jaw is broken off as complained.During the performed evaluation no manufacturing related issue could be detected.Based on the provided information it is not possible to determine the exact cause of this breakage.The strong impression marks on the holding surfaces of the cutter are an indication that may be the plates were not properly inserted, this could lead to a damage of the cutting edges like in this case and finally to a mechanical overload with a breakage of the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part number: 03.130.270.Lot number: t155143.Manufacturing site: tuttlingen.Release to warehouse date: 30-jan-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.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: PLATE CUTTER/IN-LINE FOR 1.3MM LCKNG/1.5-2.0MM VAL PL
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11176964
• MDR Text Key: 227061954
• Report Number: 8030965-2021-00339
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 07611819690721
• UDI-Public: (01)07611819690721
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.130.270
• Device Lot Number: T155143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1