MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LATERAL QUICK INSERTER/DISTRACTOR; MISC ORTHO SURGICAL INSTR

Model Number	03.809.921
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: investigation flow: functional/device interaction and damage.Visual inspection: the lateral quick inserter/distractor (p/n: 03.809.921, lot number: 3067030) was received at us cq.Visual inspection of the complaint device showed the screw that holds the u stop in place is missing, the paddles are bent, and the pusher will not rotate on its shaft.Functional test: a functional assessment was performed on the device.The pusher cannot rotate clockwise or clockwise on its shaft even with added leverage from pliers.Since it cannot rotate, the pusher cannot be twisted down the paddles.The complaint was able to be replicated.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection could be performed due to device design.Document/specification review: no design issues or discrepancies were identified.Complaint confirmed? yes.Conclusion: this complaint is confirmed since the device is functionally broken: a component is missing, the paddles are bent, and the pusher cannot rotate.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 history lot: part: 03.809.921, lot: 3067030, manufacturing site: haegendorf, release to warehouse date: jan 23, 2009.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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 (b)(6) 2019, during evaluation at loaner department, it was found out that the lateral quick inserter distractor has a broken guide bar.There was no patient involvement.This is report 1 of 1 for (b)(4).

• Brand Name: LATERAL QUICK INSERTER/DISTRACTOR
• 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: 9517748
• Report Number: 2939274-2019-62780
• Device Sequence Number: 13601991
• Product Code: LXH
• UDI-Device Identifier: 10705034726700
• UDI-Public: (01)10705034726700
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2019

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: 03.809.921
• Device Catalogue Number: 03.809.921
• Device Lot Number: 3067030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 12/25/2019
• Patient Sequence Number: 1