MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS 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 Consequences Or Impact To Patient (2199)

Event Date 06/26/2019

Event Type  malfunction  

Manufacturer Narrative

The device was 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 cutting pliers broke during first time use.No further information provided.This report is for one (1) plate cutter/in-line for 1.3 mm lckng/1.5-2.0 mm 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.A broken cutting pliers was returned for investigation.Instrument was forwarded to the manufacturing site and was checked for conformance to the specifications.The review of the device history record revealed that this instrument was manufactured in june 2018 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.The dimensional re-inspection, the hardness parameters at the time of manufacturing and the document/specification review didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.No manufacturing related issues that would have contributed to this complaint were found.The exact cause of failure could not be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot , part number: 03.130.270, lot number: t155176, manufacturing site: tuttlingen, release to warehouse date: 04-jun-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): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8836838
• MDR Text Key: 152504970
• Report Number: 8030965-2019-66611
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2019

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: 03.130.270
• Device Lot Number: T155176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2019
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 07/29/2019
• Supplement Dates Manufacturer Received: 09/02/2019
• Supplement Dates FDA Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1