MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG

Model Number	03.100.045
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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.Reporter is a j&j sales representative.Without a lot number the device history records review could not be completed.Product was not returned.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 during a pelvic surgery on (b)(6) 2021, the t-15 stardrive screwdriver will not retain the pelvic screws and the surgeons have increased difficulty in keeping the drivers engaged to the screws as they insert the screws.No further information provided.This report is for one (1) stardrive screwdriver shaft t15 250mm long.This is report 2 of 3 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.H3, h4, h6: manufacturing location: supplier - universal punch / cleaned, laser marked, inspected, packaged and released by: monument.Release to warehouse date: 02-oct-2019.Part number: 03.100m045, stardrive screwdriver shaft t15 250 mm long.Lot number: 10l5208 (non-sterile).Lot quantity: 102.One piece was scrapped in ultrasonic clean, for an unacceptable surface finish (dings / scratches).Production order traveler met all inspection acceptance criteria apart from the one piece noted.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Inspection sheet, incoming inspection met all inspection acceptance criteria.Certificate of compliance was reviewed and determined to be conforming.Certificate of tests was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Isual inspection: the stardrive screwdriver shaft t15 250mm long (part # 03.100.045, lot # 10l5208) was received at us customer (cq).Upon visual inspection, the screwdriver shaft had minor surface scratches.The hexalobe of the device was inspected and no damage that could prevent the screwdriver to engage with the screw was observed.Functional test: a functional test was not performed as the screwdriver was not returned with the screw.Can the complaint be replicated with the returned devices? unable to perform.Dimensional inspection: the diameter of the shaft was measured to be within the specified dimensions.Measuring device: hand micrometer.Document/ specification review: the following documents were reviewed: t-15 screwdriver shaft stardrive 250mm: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: the complaint condition cannot be confirmed for the stardrive screwdriver shaft t15 250mm long (part # 03.100.045, lot # 10l5208) as there was no defect that could have contributed to the reported allegation.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventive 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: STARDRIVE SCREWDRIVER SHAFT T15 250MM LONG
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11977580
• Report Number: 2939274-2021-02882
• Device Sequence Number: 3604882
• Product Code: HXX
• UDI-Device Identifier: 10886982070944
• UDI-Public: (01)10886982070944
• 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
• 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
• Report Date (Section B): 05/19/2021

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: 03.100.045
• Device Catalogue Number: 03.100.045
• Device Lot Number: 10L5208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA