MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PADR MALEÁV P/PL-LOCK2 P/MANDÍB GR 20F; TEMPLATE

Catalog Number	329.524
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, the bending template was found to be broken during reverse logistics audit of returned device at a third party servicer.There was no patient involvement and no additional information is available.This report is for one (1) padr maleáv p/pl-lock2 p/mandíb gr 20f.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Visual inspection: the complaint device 2.0mm locking plate template (product code: 329.524, lot number: unk) was returned to cq west chester for investigation.During visual inspection, the plate was found broken.Only a part of the broken plate was returned for investigation.Document /specification review: the manufacturing date of the device was not available, hence the current revision of the drawing was reviewed.2.0mm locking plate template, 329_524 rev e (current).Dimensional inspection: according to 329_524 rev b, diameter of hole templates: 6.5 mm ± 0.2 mm (specified dimension).Diameter of hole templates: 6.39 mm (measured dimension, conforming).Measurement device used: caliper ((b)(4)).Conclusion: the returned plate was broken, hence the complaint was confirmed.A definitive root cause was not determined during investigation.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.Device history lot: the lot number of the device was not available, hence a dhr review could not be completed.If the lot number becomes available in the future, the dhr review will be completed.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: PADR MALEÁV P/PL-LOCK2 P/MANDÍB GR 20F
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12934363
• Report Number: 2939274-2021-06963
• Device Sequence Number: 4906349
• Product Code: HWT
• UDI-Device Identifier: 07611819755659
• UDI-Public: (01)07611819755659
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 10/19/2021

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: 329.524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PADR MALEÁV P/PL-LOCK2 P/MANDÍB GR 20F
• Patient Sex: Unknown