MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LOCKING CALCANEAL PLATE CUTTER; INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number	329.151
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j sales representative.The device has been received, the investigation is in progress, 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.
Event or Problem Description
It was reported that on an unknown date, the positioning knob of the locking calcaneal plate cutter fell off.The issue was found before delivering a loaner tray to a hospital.There was no patient involvement.This report is for one (1) locking calcaneal plate cutter.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: part: 329.151 lot: 2343259 manufacturing site: bettlach release to warehouse date: march 31, 2008 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the locking calcaneal plate cutter (p/n 329.151 lot 2343259) was received at us customer quality (cq).Upon visual inspection it was noticed that the peg component was broken off from the device.The peg was not returned at uscq.No other issues were identified with the returned components of the device.Device failure/defect identified? yes dimensional inspection: dimensional inspection was not performed due to the confirmed post manufacturing damage and the broken component was not returned to measure the relevant feature of the peg.Document/specification review: the following design drawings were reviewed during this investigation.Locking calcaneal plate cutter assembly design drawing locking calcaneal plate cutter assembly design drawing conclusion: the complaint condition is confirmed for the locking calcaneal plate cutter (p/n 329.151 lot 2343259) as the peg component was broken off.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.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: LOCKING CALCANEAL PLATE CUTTER
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10891319
• Report Number: 2939274-2020-05279
• Device Sequence Number: 3285517
• Product Code: HTZ
• UDI-Device Identifier: 10886982191854
• UDI-Public: (01)10886982191854
• Combination Product (Y/N): N
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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: 329.151
• Device Catalogue Number: 329.151
• Device Lot Number: 2343259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1