MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STRONG ARM CONNECTOR; MISC ORTHO SURGICAL INSTR

Model Number	03.816.801
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product investigation was conducted.Visual inspection: the instrument was received at us cq and upon inspection it can be seen that the distal threads of the locking nut broke (not returned) preventing the device from functioning as intended.No other issues were identified.A device failure was identified.Dimensional inspection: a dimensional inspection was not performed due to post manufacturing damage.Document/specification review: the relevant drawings were reviewed: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During the investigation no unidentified product design/manufacturing issues or discrepancies 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.A device history record (dhr) review was conducted: part: 03.816.801, lot: 9345913, manufacturing site: (b)(4), release to warehouse date: 13.April 2015, 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 on (b)(6) 2020, during inspection of set at loaners department it was found out that the screw of a strong arm connector was damaged.There was no patient involvement.During manufacturer's investigation of the returned device it was identified that the distal threads of the locking nut broke (not returned) preventing the device from functioning as intended.This is report 1 of 1 for complaint (b)(4).

• Brand Name: STRONG ARM CONNECTOR
• 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: 9912269
• Report Number: 2939274-2020-01660
• Device Sequence Number: 3423402
• Product Code: LXH
• UDI-Device Identifier: 10705034731124
• UDI-Public: (01)10705034731124
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/13/2020

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: 03.816.801
• Device Catalogue Number: 03.816.801
• Device Lot Number: 9345913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1