MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE HEXAGONAL SCREWDRIVER SHAFT

Model Number	314.15
Medical Device Problem Codes	Device-Device Incompatibility (2919); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: initial reporter is syntheses sales representative without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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), 2021, the large hexagonal screwdriver shaft have a small nick in the ao connector portion and the scrub tech was having a difficult time getting the power hex drive to seat properly into the quick connect.There was no surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report is for one (1) large hexagonal screwdriver shaft this is report 1 of 1 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.H3, h4, h6: part # 314.15-us.Lot # 3600956.Manufacturing site: werk hagendorf.Release to warehouse date: november 4, 2010.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the large hexagonal screwdriver shaft was received at juarez pal.Visual examination of the returned device found the coupling end is nicked.No other product defect identified.Functional test: an attempt to assemble the returned hexagonal screwdriver shaft to a sample depuy quick coupling torque limiting handle, was unsuccessful.The investigation was able to replicate the complaint condition.Device failure/defect identified? yes.Dimensional inspection: feature: coupling shaft.Result: conforming.Measurement device: caliper.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint was confirmed for the received device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 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: LARGE HEXAGONAL SCREWDRIVER SHAFT
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13392169
• Report Number: 2939274-2022-00291
• Device Sequence Number: 4253247
• Product Code: HXX
• UDI-Device Identifier: 10886982188595
• UDI-Public: (01)10886982188595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 314.15
• Device Catalogue Number: 314.15
• Device Lot Number: 3600956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown