MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM TI MLP ADAPTION PLATE- MINI 12 HOLES; BONE PLATE

Model Number	447.050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
It was reported that on (b)(6) 2019, a titanium (ti) mini mandible locking plate (mlp) adaption plate was noted to be broken during reverse logistics audit of the returned devices at millstone.There was no patient involvement and no additional information is available.This report is for one (1) 2.0mm ti mlp adaption plate- mini 12 holes.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.Part: 447.050.Lot: 5313502.Product release: august 17, 2006.A manufacturing related potential cause was not suspected, therefore, per procedure, no manufacturing record evaluation is required.Visual inspection: the 2.0mm ti mlp adaption plate- mini 12 holes was received at customer quality, and it was observed that the plate was broken into 3 pieces.All three pieces were returned for investigation.The complaint of broken (2+ pieces) is confirmed.Dimensional inspection: the ø 2.4 of the plate proximal to the breakage was measured.Drawing: 2.0mm mlp adaption plate 12 hole, mini.Conclusion: the measuring result does show conformity.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.Document/ specification review: the following document(s) were reviewed: 2.0mm mlp adaption plate 12 hole, mini a cursory inspection of the complaint file for the device that was found damaged does not point to a manufacturing issue.Therefore a dhr/mre is not required.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however, no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique ,or different patient harms were identified because of this evaluation.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.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: 2.0MM TI MLP ADAPTION PLATE- MINI 12 HOLES
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9286177
• Report Number: 2939274-2019-61999
• Device Sequence Number: 13936823
• Product Code: JEY
• UDI-Device Identifier: 10887587052601
• UDI-Public: (01)10887587052601
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K974555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2019

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: 447.050
• Device Catalogue Number: 447.050
• Device Lot Number: 5313502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/03/2019
• Patient Sequence Number: 1