MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BEND-TEMPL SM L69; TEMPLATE

Model Number	329.607
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/09/2019
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.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 during the surgery the malleable template being used to adapt it to the patient's anatomy, was broken when the tongue was folded.It was already weak enough to break.This report is for one (1) bend-templ sm l69.This is report 1 of 1 for (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 device was received, the investigation is in progess, 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.Initial reporter reporters state: (b)(6).Lot number alert date correction to 10/11/2019 from 10/101/2019.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.
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.Investigation flow: damage.Visual inspection: bend-templ sm l69 was received at us cq.Upon visual inspection at cq, it is observed that the small part of the bending template got broken.It is also observed that the device was deformed at multiple location.There were few scratches observed on the surface of the device.Thus, the complaint is being confirmed.Device failure/ defect found? yes.Dimensional inspection (calipers: ca818): the width of the device near to the broken location was intended to be measuring from 2.8mm to 3.2mm and it was measured to be 2.91mm which is within specifications as per the drawing 329_607 rev.F.Document/ specification review: the following relevant drawings were reviewed during investigation: -bending template, short locking calcaneal plate: 329_607 rev.F no design issues were found which can contribute to this complaint condition.Complaint confirmed? yes.Investigation conclusion: a visual inspection, dimensional inspection, and document/ specification review were performed as part of this investigation.The complaint is being confirmed as the small part of the device got broken.While a definitive root cause could not be determined, it is possible that no product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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 history lot.Part # 329.607.Synthes lot # h480635 supplier lot # h480635 release to warehouse date: jan 18, 2018 supplier: tech-etch, inc.No ncr's were generated during production.Device history review review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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: BEND-TEMPL SM L69
• Common Device Name: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9247054
• Report Number: 8030965-2019-69748
• Device Sequence Number: 18944775
• Product Code: HWT
• UDI-Device Identifier: 10886982192103
• UDI-Public: (01)10886982192103
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2019

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
• Operator of Device: Health Professional
• Device Model Number: 329.607
• Device Catalogue Number: 329.607
• Device Lot Number: H480635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/22/2019; 12/04/2019; 12/12/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/28/2019; 12/10/2019; 12/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1