MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCALPEL HANDLE F/LCP PERIART AIMING INSTRUMENT SET-LARGE; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.120.016
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 synthes employee.Product code 03.120.016.Lot number 8404253.Manufacturing site: (b)(6).Release to warehouse date: june 28, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the scalpel handle f/lcp periart aiming instrument set-large (p/n: 03.120.016, lot #: 8404253) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the laser weld between the scalpel tip and scalpel core components was broken and the scalpel tip was separated from the device.No other issues were observed with the returned device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Scalpel assembly.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the scalpel handle f/lcp periart aiming instrument set-large (p/n: 03.120.016, lot #: 8404253).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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 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, during routine incoming inspection of a loaner set at the field service location, it was observed that the scalpel handle for periarticular aiming arm instrument was broken.There was no known patient or hospital involvement.This report involves 1 scalpel handle f/lcp periart aiming instrument set-large.This is report 1 of 1 for (b)(4).

• Brand Name: SCALPEL HANDLE F/LCP PERIART AIMING INSTRUMENT SET-LARGE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11399134
• Report Number: 2939274-2021-01121
• Device Sequence Number: 1166617
• Product Code: FZX
• UDI-Device Identifier: 10886982074140
• UDI-Public: (01)10886982074140
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 03.120.016
• Device Catalogue Number: 03.120.016
• Device Lot Number: 8404253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1