MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8; GUIDE

Model Number	314.468
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was 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 on an unknown date, the holding sleeve was sticking on the shaft of the screwdriver intraoperatively.There was no patient harm.This is report 1 of 2 for (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.Investigation summary.Visual inspection: the holding sleeve for stardrive screwdriver shaft t8 (p/n: 314.468, lot #: 7640370) was returned and received at us cq.Upon visual inspection, there was a slight discoloration observed on the collet component but have no impact on the device functionality.No other issues were identified with the returned components of the device.Functional test: the functional test was performed on the returned devices.The returned stardrive screwdriver shaft t8 105 mm (p/n: 314.467, lot #: 9852765) was assembled with the returned holding sleeve.There were no issues identified during assembling.But the screwdriver shaft was not able to disassemble from the holding sleeve.The coupling sleeve was removed to disassemble the shaft from the holding sleeve.The stardrive screwdriver shaft was investigated under a different pi.Can the complaint be replicated with the returned devices? yes.Service & repair evaluation: the customer reported the holding sleeve was sticking on the shaft of the screwdriver.The repair technician reported the device failed to operate smoothly and nonbinding.The damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is the damaged component.The item will be forwarded to customer quality.The evaluation was confirmed.Dimensional inspection: the dimensional inspection was performed on the returned device.The outer diameter of the device was measured to be 4.51 mm (ca 215p).This is within the specification of 4.55 +0/-0.1 mm, per collet 2.4 locking screw.The inner diameter of the device was measured to be 4.10 mm (ca 215p).This is within the specification of 4.10 +/-0.2 mm, per collet 2.4 locking screw.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed.Holding sleeve 2.4 dia locking screw.Collet 2.4 locking screw.Complaint confirmed? yes, the device received was unable to disassemble.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the holding sleeve for stardrive screwdriver shaft t8 (p/n: 314.468, lot #: 7640370).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.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 part # 314.468.Synthes lot # 7640370.Supplier lot # na.Release to warehouse date: 02 apr 2014.Manufactured by synthes jennersville.No ncr's were generated during production.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: HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9801331
• Report Number: 2939274-2020-01178
• Device Sequence Number: 653750
• Product Code: FZX
• UDI-Device Identifier: 10886982188939
• UDI-Public: (01)10886982188939
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: 314.468
• Device Catalogue Number: 314.468
• Device Lot Number: 7640370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/02/2020
• Patient Sequence Number: 1