MAUDE Adverse Event Report: SYNTHES GMBH BENDING TEMPLATE FOR 3.5MM LP CRVD RECON PL-108MM RAD/16H

Catalog Number	03.100.037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.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 on (b)(6) 2021 the drill bit loses its edge after several uses and does not drill any more.At the time that the specialist performed maneuvers to shape the template with the patient's bone, it broke without using any force.Procedure was completed successfully without any surgical delay.This report is for one (1) bending template for 3.5mm lp crvd recon pl-88mm rad/16h.This is report 2 of 2 for complaint (b)(4).
Additional 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.The lot number on the device is not legible, therefore a manufacturing record evaluation cannot be performed.Visual inspection: the bend-templ f/lowprofile3.5 recopl-curved (product code: 03.100.037, lot number: unk) was received at us customer quality (cq).Visual inspection of the device noted that it was broken into multiple pieces.Sections of the anodization were worn off, likely as a result of repeated bending.Part of the etching on the device has become illegible due to the wearing of the anodization.No other device defects were noted.Device failure/defect identified? yes document/specification review: the following drawings were reviewed: current and manufactured revisions revision f of the drawing had a discrepancy regarding the location of the etchings on the part.Since the lot number is not known, older revisions of the part drawings were reviewed.The part was found to be conforming to the manufactured revision drawing, and no other design or manufacturing discrepancies were noted.Dimensional inspection: a dimensional inspection cannot be performed due to post manufacturing damage.Complaint confirmed? yes conclusion: the complaint is confirmed for the returned device as the bend template is broken.A definitive assignable root cause cannot be determined from the provided information.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.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.D1 d4: catalog and udi.Lot is unknown.
Additional 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 - codes updated to imdrf codes.Device history lot - a manufacturing record evaluation was performed for the finished article lot 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.

• Brand Name: BENDING TEMPLATE FOR 3.5MM LP CRVD RECON PL-108MM RAD/16H
• Common Device Name: TEMPLATE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12490904
• Report Number: 8030965-2021-07850
• Device Sequence Number: 3392491
• Product Code: HWT
• UDI-Device Identifier: 07611819796799
• UDI-Public: (01)07611819796799
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2021

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: 03.100.037
• Device Lot Number: L395062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/22/2021; 10/25/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/22/2021; 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DRILL BIT Ø2.5 CALIBR L300 W/QUICK-COUPL.
• Patient Sex: Unknown