MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFRAME EXTENSION-ADJUSTABLE; MISC ORTHO SURGICAL INSTR

Model Number	387.334
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Part: 387.334, lot: l881359, manufacturing site: (b)(6), release to warehouse date: 14.May 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the synframe extension-adjustable (part # 387.334, lot # l881359, mfg # 14-may-2018) was received at us customer quality (cq) with the extension adjusted to an angle and tightened.Functional test: the screw that holds the structure in place was very tight and a lot of force was required to untighten it.The screw could only be untightened to a certain point and then jammed again.Even though the device is not deformed or bent, it is in the bent state and unable to be changed to the original position, therefore the complaint is confirmed.Dimensional inspection: dimensional analysis was not performed as relevant features are inaccessible.Document/specification review: the following drawing(s) was reviewed; - verlaeng m/rastverrieg.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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.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 february 17, 2020, during evaluation of the devices two (2) synframe extensions were found unable to be straightened.There was no patient involvement.This report is for one (1) synframe extension-adjustable.This is report 2 of 2 for (b)(4).

• Brand Name: SYNFRAME EXTENSION-ADJUSTABLE
• 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: 9912433
• Report Number: 2939274-2020-01664
• Device Sequence Number: 3354859
• Product Code: LXH
• UDI-Device Identifier: 10705034771038
• UDI-Public: (01)10705034771038
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2020

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: 387.334
• Device Catalogue Number: 387.334
• Device Lot Number: L881359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2020
• 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