MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH QUICK COUPLING; MISC ORTHO SURGICAL INSTR

Model Number	03.111.038
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product code: hxx.Reporter is j&j employee.A product investigation was conducted.Visual inspection: visual inspection performed at customer quality observed that swirling cap (not returned) broke from coupling portion of the instrument resulting in the complaint condition.No other issues were observed.A device failure was identified dimensional inspection: a dimensional inspection could not be performed due to post manufacturing damage and the cap not being returned.Document/specification review: the relevant drawing(s) was reviewed; review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Investigation conclusion: a definitive root cause for the device breakage could not be determine it is possible that the device encountered unintended forces (during usage) that led to observed condition.The overall complaint condition is confirmed.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.A device history record (dhr) review was conducted: part: 03.111.038.Lot: l821493.Manufacturing site: (b)(4).Release to warehouse date: 10.Apr.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 a routine incoming inspection of a loaner set, a handle with quick coupling was observed broken.There was no patient and procedure involvement.This report is for one (1) handle with quick coupling.This is report 1 of 1 for complaint (b)(4).

• Brand Name: HANDLE WITH QUICK COUPLING
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9070866
• Report Number: 2939274-2019-60589
• Device Sequence Number: 2529653
• Product Code: LXH
• UDI-Device Identifier: 10886982072368
• UDI-Public: (01)10886982072368
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

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: 03.111.038
• Device Catalogue Number: 03.111.038
• Device Lot Number: L821493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1