MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SLIP SLEEVE FOR THREADED HOLDING SLEEVE; MISC ORTHO SURGICAL INSTR

Catalog Number	03.614.036
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records has been requested.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.
Event or Problem Description
It was reported that on an unknown date, it was discovered that a screwdriver assembly was stuck and could not be disassembled during routine inspection.The devices involved were a hex screwdriver and slip sleeve that could not be removed from the holding sleeve.There was no patient involvement.This report is for one (1) slip sleeve for threaded holding sleeve.This is report 1 of 2 for complaint (b)(4).
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: part: 03.614.036; lot: 1678909; manufacturing site: hägendorf; release to warehouse date: july 17, 2007.The device history record shows this lot 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.Visual inspection: visual inspection of the device shows the device is jammed with the driver sleeve and screw driver shaft assembly.There is no damage with the device and is in fair condition.Functional test: a functional test was performed with all three devices and they could not be separated, even with the use of force.However, the issue lies with the driver sleeve and driver shaft as the interaction between the spring of the sleeve and proximal end of the driver are jammed and all three devices can¿t be disassembled as intended.The received condition does agree with the complaint description, however the holding sleeve did not contribute to the issues and is unconfirmed.Document/specification review the following drawing(s) was reviewed; --spring loaded threaded driver sleeve no design or manufacturing defect or deficiency was observed during the investigation.A device history review was performed for the returned instrument¿s lot number, and no nonconformance reports (ncrs), no material review reports (mrrs), or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Investigation conclusion: no root cause could be determined as no issues were found that would contribute to the complaint and the complaint is unconfirmed.Instead the issue lies with the other two devices.During this investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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.

• Brand Name: SLIP SLEEVE FOR THREADED HOLDING SLEEVE
• 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: 8278101
• Report Number: 2939274-2019-56069
• Device Sequence Number: 14033901
• Product Code: LXH
• UDI-Device Identifier: 10705034715049
• UDI-Public: (01)10705034715049
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 01/07/2019

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 Catalogue Number: 03.614.036
• Device Lot Number: 1678909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1