MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM SETSCREW EXTRACTOR; MISC ORTHO SURGICAL INSTR

Model Number	03.611.030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: reporter is j&j employee.A product investigation was conducted.Visual inspection: it was noticed that the distal tip of the device was broken off and it was not returned.Hence the complaint can be confirmed.Yes device is broken.Dimensional inspection: proper dimensional measurement could not be preformed due to post manufacturing damage.Investigation conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown.It is possible that the device encountered unintended forces (such as being dropped or damaged during sterile processing during its service life).During the investigation no unidentified product design / manufacturing issues or discrepancies 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.A device history record (dhr) review was conducted: part number: 03.611.030, synthes lot number: 6309043, supplier lot number: n/a, release to warehouse date: 31 mar 2010, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.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 loaner set, the set screw extractor was observed broken.There was no known hospital or patient involvement.This report is for one (1) 1.5 mm set screw extractor.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 1.5MM SETSCREW EXTRACTOR
• 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: 9084315
• Report Number: 2939274-2019-60684
• Device Sequence Number: 2923840
• Product Code: LXH
• UDI-Device Identifier: 10705034713830
• UDI-Public: (01)10705034713830
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/21/2019

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: 03.611.030
• Device Catalogue Number: 03.611.030
• Device Lot Number: 6309043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1