MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION SLEEVE FOR 5.0MM TI LOCKING SCREWS; GUIDE

Catalog Number	324.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history records has been requested.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during inspection on (b)(6) 2018, two devices were having a problem.The insertion sleeve that is supposed to hold the drill guide or wired guide, gets stuck when it is inserted.On another insertion sleeve, the wired ring that goes around the aiming arm was bent up and will not fit.There was no patient involvement.This report is for one (1) insertion sleeve for 5.0mm ti locking screws.This is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was conducted: part: 324.022.Lot: 2148731.Manufacturing site: (b)(4).Release to warehouse date: 25.Aug.2005.The device history record shows this lot of (b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product 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.
Additional Manufacturer Narrative
Supplier lot number reported as: 2148731.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: product investigation was completed.The insertion sleeve was received with significant bending of the spring ring component.The ring is bent at a roughly 90 degree angle out of the intended plane such that it protrudes from the intended grove.The ring then shows another roughly 90 degree angle aligning it with the adjacent groove in the insertion sleeve.In addition, a dent was observed on the distal edge of the sleeve and the port component was observed to be bent distally at the welded connection and showed scraping and indents consistent with tool markings along the outer diameter.The balance of the device shows surface wear consistent with use and which would not impact the functionality.The complaint condition could not be replicated as the mating device was not received.However, the post manufacturing damage to the ring would contribute to the reported fit issue.Thus, it was determined that the received condition does agree with the complaint description as the spring ring was observed to be bent which would impact the fit with the mating aiming arm.This matched the reported condition of ¿the wired ring that goes around the aiming arm was bent up and will not fit.¿ the outer diameter of the spring ring subcomponent at the bend measured 0.98mm to 1.00mm which is within the specification of 1mm +/-0.03 [0.97-1.03] per drawing.Measured using calipers ca592.The outer diameter of the sleeve adjacent to the dent on the distal end of the device measured 8.66mm which is within the specification of 8.7mm +0/-0.1 [8.7-8.6] per drawing.The inner diameter of the sleeve adjacent to the dent on the distal end of the device measured 7.40mm which is within the specification of 7.4mm +0.04/-0.03 [7.37-7.44] per drawing.Measured using calipers ca592.Inspection of the port component could not be conducted due to the post manufacturing deformation and location of the bend at the welded connection.Relevant drawings, reflecting the current and manufactured revision, were reviewed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint condition is confirmed as the spring ring component was observed to be bent which would impact the function with the mating device as reported.In addition, a dent was observed on the distal edge of the sleeve and the port component was observed to be bent distally at the welded connection and showed scraping and indents along the outer diameter.No design or manufacturing defect or deficiency was observed during the investigation.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.However, the received condition is consistent with rough handling and cumulative wear from the approximate 13 year lifespan.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Lot number 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: INSERTION SLEEVE FOR 5.0MM TI LOCKING SCREWS
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7946786
• Report Number: 2939274-2018-54256
• Device Sequence Number: 1665210
• Product Code: FZX
• UDI-Device Identifier: 10886982190949
• UDI-Public: (01)10886982190949
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/18/2018

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: 324.022
• Device Lot Number: 2148731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018; 10/15/2018; 10/17/2018; 11/09/2018; 11/12/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 10/09/2018; 10/16/2018; 10/18/2018; 11/09/2018; 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1