MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BENDING TEMPLATE 6 X 23 HOLES F/ANGLED RECONSTRUCTION PLATES

Model Number	329.769
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: manufacturing location: (b)(4), manufacturing date: 30-mar-2000, part number: 329.769, bending template 6 x 23 holes f/angled reconstruction plate, lot number: 4066264 (non-sterile), lot quantity: 27.Work order traveler met all inspection acceptance criteria.Inspection sheet met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Visual inspection: the bending template 6 x 23 holes f/angled reconstruction plates (p/n 329.769) was received at customer quality (cq), and it was observed that distal end of the plate was broken off.The broken part was not returned.The complaint of broken (2+ pieces) is confirmed.Device failure/ defect identified? yes.Dimensional inspection: the minor diameter 4.75 +/- 0.20mm of the plate got measured.Minor diameter: 4.75 +/- 0.20mm, caliper: ca 215p, measured diameter = 4.80 mm.Conclusion: the measuring result does show conformity.The major diameter 8 +/- 0.2mm of the plate got measured.Major diameter: 8 +/- 0.2mm, caliper: ca 215p, measured diameter = 7.99 mm.Conclusion: the measuring result does show conformity.Document/ specification review: the respective drawing(s) was reviewed this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Complaint confirmed? yes.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.
Event or Problem Description
It was reported that on (b)(6) 2019, the bending plate was found to be broken during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves one (1) device.This report is for one (1) bending template 6 x 23 holes f/angled reconstruction plates.This is report is 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.H11 corrected data: h4 (device manufacture date).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 6 X 23 HOLES F/ANGLED RECONSTRUCTION PLATES
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9162122
• Report Number: 2939274-2019-61232
• Device Sequence Number: 19428968
• Product Code: HWT
• UDI-Device Identifier: 10887587039848
• UDI-Public: (01)10887587039848
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 329.769
• Device Catalogue Number: 329.769
• Device Lot Number: 4066264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1