MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SILICONE INSERT F/INLINE PL CUTTER 03.130.270; PLIERS, SURGICAL

Catalog Number 03.130.270

Device Problem Break (1069)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 (b)(6) reports an event as follows: it was reported that on an unknown date that one of the pliers jaws has snapped off.This case has been reported by the loan kit technician during loan kit inspection.This report is for one (1) silicone insert f/inline pl cutter 03.130.270.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: h6: updated codes to imdrf codes h3, h6: a product investigation was conducted.Visual inspection: the visual inspection of the complained cutting pliers has shown that the lower cutting jaw is broken off.Apart from that the instrument shows signs of use, such as scratches and dents on the handles.Dimensional inspection: the relevant features are heavy damaged in a manner which prevents accurate measurement of the features.However the part conformed to dimensional specifications at the time of manufacturing and passed inspection requirements.Document/specification review: the manufacturing specification were reviewed, and this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.The review has shown that the correct material was used, and that the hardness was within the specification.Summary: the received condition of the cutting pliers is concordant with the complaint description and the complaint condition is confirmed.This lot was manufactured in january 2020 according to the specification.Unfortunately we are not able to determine the exact cause which has led to the damage.We only can assume that a mechanical overloading situation, has caused the damages.The complained part was forwarded to ms&t for further evaluation.The result of this investigation confirmed that no product design or manufacturing issues were observed that may have contributed to the complaint condition; the investigation performed could not detect any material faults.The microstructure of the used material was examined in a metallographic section cut and found to be according to the standards.There were no irregularities (i.E.Nonmetallic inclusions etc) or signs of embrittlement evident.Even if the observed carbides embedded in the dimples are common for a stainless steel with this hardness, it is notable that the carbide rows are oriented in the direction of crack propagation (dcp).The snapped off jaw is a result of an overload of the device.The observed dimple structure on the entire fracture surface is a clear indication of a ductile forced fracture.It can be assumed that the jaw broke during an instantaneous overloading.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.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 as no product related issue could be detected.H6: a device history record (dhr) review was conducted: part number: 03.130.270 lot number: t186954 manufacturing site: tuttlingen release to warehouse date: 02-jan-2020 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: SILICONE INSERT F/INLINE PL CUTTER 03.130.270
• Type of Device: PLIERS, SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10757095
• MDR Text Key: 213898456
• Report Number: 8030965-2020-08364
• Device Sequence Number: 1
• Product Code: HTC
• UDI-Device Identifier: 07611819690721
• UDI-Public: 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• 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: T186954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Date Manufacturer Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1