MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number	03.632.037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is a synthes sales consultant.Part 03.632.037, lot 6707906: release to warehouse date: november 11, 2011.Supplier: (b)(4).No non-conformance reports (ncr's) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was completed: the returned head placement tool was missing the blocker component, which is welded to the outer shaft component.The weld was therefore broken.Cosmetic wear consistent with the device use was observed to the outer shaft; this wear would not affect performance of the device.The received condition agreed with the complaint description.Therefore, the complaint was confirmed.A dimensional inspection could not be performed due to the received condition of the weld.Review of the device history record (dhr) revealed no manufacturing issues related to the complaint.Relevant drawings for the returned instrument were reviewed.No design issues were observed.The complaint was confirmed with investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined; however, it is likely that the device experienced excessive and/or off-axis forces.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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 that on unknown date, the polyxial head placement tool for matrix had a damaged end piece when putting the kit back together.The damage was noticed when the instrument was being threading back together.There was no patient involvement.When the received device was being investigated by the manufacturer, it was noted that the head placement tool was missing the blocker component, which is welded to the outer shaft component.The weld was therefore broken.This report is for a polyxial head placement tool for matrix.This is report 1 of 1 for (b)(4).

• Brand Name: POLYAXIAL HEAD PLACEMENT TOOL FOR MATRIX
• 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: 8240418
• Report Number: 2939274-2019-55795
• Device Sequence Number: 1557942
• Product Code: LXH
• UDI-Device Identifier: 10705034718958
• UDI-Public: (01)10705034718958
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/15/2018

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 Catalogue Number: 03.632.037
• Device Lot Number: 6707906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1