MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC JOINT PREP/CHISEL/20 DEG BEND NARROW/10MM WIDE; CHISEL, SURGICAL, MANUAL

Model Number	03.111.017
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 unknown date, during inspection it was identified that the joint prep/chisel/20 deg bend narrow 10 was dented.It was noted that possibly unsafe to use.This report is for one (1) joint prep/chisel/20 deg bend narrow/10mm wide.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Reporter is a j&j sales representative.The subject 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.
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.H3, h6: a product investigation was conducted.Visual inspection: the joint prep/chisel/20 deg bend narrow 10 (part# 03.111.017, lot# 20533501 , qty# 1) was received at west chester, cq.A visual inspection was performed on the devices and confirmed that the cutting edge of the chisel was found deformed.No other issues were identified with the device.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: based on the date of manufactured, the current and the manufactured drawings were reviewed: no design issue or discrepancy was found.Investigation conclusion: the overall complaint was confirmed.The minor deformation of the edge could have happened due to the repetitive use of device during surgical procedures.Although no definitive root-cause can be determined it¿s possible that the device might have experienced unintended forces during use/handling.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.Date of manufacture: 12-nov-2020.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.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: JOINT PREP/CHISEL/20 DEG BEND NARROW/10MM WIDE
• Common Device Name: CHISEL, SURGICAL, MANUAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12556199
• Report Number: 2939274-2021-05832
• Device Sequence Number: 924628
• Product Code: FZO
• UDI-Device Identifier: 10886982072160
• UDI-Public: (01)10886982072160
• 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): 09/01/2021

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 Model Number: 03.111.017
• Device Catalogue Number: 03.111.017
• Device Lot Number: 20533501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1