MAUDE Adverse Event Report: SYNTHES GMBH MATRIXMANDIBLE SHORT CUT PLATE CUTTER; INSTRUMENT, CUTTING, ORTHOPEDIC

Catalog Number	03.503.057
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: two matrixmandible short cut plate cutters (p/n: 03.503.057, lot number: l574886) were received at us cq.Upon visual inspection, the cutting head jaws of both the cutters were dull and deformed.Additionally scratches from field usage were observed on the devices, which do not affect the functionality.No other issues were identified.Functional test cannot be performed as the devices were returned by itself.However, the damaged cutting edges could have caused the complaint condition.No dimensional inspection can be performed due to post manufacturing damage.Document/specification review: relevant drawings were reviewed.No design issues or discrepancies were identified.This complaint is confirmed the cutting head jaws are damaged.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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.A device history record (dhr) review was conducted: part: 03.503.057, lot: l574886, manufacturing site: (b)(4).Release to warehouse date: 21 sep 2017.A manufacturing record evaluation 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an open reduction internal fixation (orif) procedure of a rib, on (b)(6) 2021, the two (2) plate benders were not cutting plates adequately.Instead of a clean cut, the plate cutters were tortioning and bending the plate.No further information provided.During manufacturer's investigation of the returned devices it was identified that the cutting head jaws of both the cutters were dull and deformed.This product condition was re-evaluated and determined to be reportable on (b)(6) 2021.This report is for one (1) matrixmandible short cut plate cutter.This is report 1 of 1 for complaint (b)(4).

• Brand Name: MATRIXMANDIBLE SHORT CUT PLATE CUTTER
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11832054
• Report Number: 8030965-2021-03968
• Device Sequence Number: 19865881
• Product Code: HTZ
• UDI-Device Identifier: 07611819894426
• UDI-Public: (01)07611819894426
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.503.057
• Device Lot Number: L574886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1