MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM/3.2MM DOUBLE DRILL SLEEVE; GUIDE

Catalog Number	312.670
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is no reported patient involvement.Date of device breakage is unknown.Device is an instrument and is not implanted/explanted.There was no procedure or patient involvement.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history records review has been requested.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) 2018, while at sterile processing, a 6.5mm cannula was noticed to have broken off from the 3.2/6.5mm drill guide upon set assembly by a staff member.There was no patient involvement.This report is for a 6.5mm/3.2mm double drill sleeve.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.A device history record (dhr) review was conducted for part: 312.670, lot: 2402383: manufacturing site: bettlach, release to warehouse date: 19.Sep.2008.The device history record shows this lot of 50 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional, visual and functional criteria at the time of release with no issues documented during the manufacturing process.Only top level of the device history record reviewed as sub-components are not lot tracked.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.A product investigation was conducted.Device condition: visual inspection performed at customer quality (cq) observed that one of the cannulated shaft for drill guide was broken at its soldering.No new issues were identified on other portions of the device.The complaint condition agrees with the complaint description and the complaint condition was confirmed.Dimensional analysis and document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.With the broken soldering identified, dimensional analysis was determined to be inapplicable.A review of the device history records on top level of the device showed that there were no issues at the time of manufacturing of this device that would contribute to the complaint condition.With the given sub components being lot tracked, material review on component level was not able to be performed.However, with the given age of device for over 9 years, it is confirmed that the given device material and its properties would not have contributed to complaint condition.Conclusion: while no definitive root cause could be determined, it is possible that with the device age of the device over 9 years and any unintended forces encountered by the device during usage could have contributed to given complaint condition.The overall complaint condition is confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation 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.

• Brand Name: 6.5MM/3.2MM DOUBLE DRILL SLEEVE
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7666927
• Report Number: 2939274-2018-52732
• Device Sequence Number: 19092904
• Product Code: FZX
• UDI-Device Identifier: 10886982187864
• UDI-Public: (01)10886982187864
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Report Date (Section B): 06/11/2018

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: 312.670
• Device Lot Number: 2402383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 07/10/2018; 08/03/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 07/26/2018; 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1