MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED SDDRIVE SCREWDRIVER T15; SCREWDRIVERS

Model Number	03.226.041
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.The investigation could not be completed, no product was received; 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, the cannulated stardrive screwdriver tip is broken, can't engage an unknown screw.The issue was observed during pre-surgery.There was no patient involvement.Concomitant device reported: unk - screw: (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for (1) cannulated sddrive screwdriver t15.This report is 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.H10 additional narrative: d9 - device received to manufacture.H6 - codes updated to imdrf codes.Visual inspection: the cannulated sd drive screwdriver t15 (part # 03.226.041, lot # 9098264) was received at us cq.Upon visual inspection, the tip of the screwdriver was observed to be broken and the broken fragment was not returned.No other issues were identified with the returned device.Functional test: a functional test was not performed on the returned device as it was returned by itself, but the broken condition could have contributed to the alleged device interaction issue.Dimensional inspection: the diameter of the shaft was measured near the broken area.The outer diameter is 3.57 mm (ca802), which complies with the specifications of 3.6 mm +0/-0.05mm, as per the drawing se_126695, rev c.Document/ specification review: the following current and manufactured revisions were reviewed: se_126691 rev c/e; se_126695 rev c.Investigation conclusion: the complaint can be confirmed as the device was broken.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces during its use.No new malfunctions were observed during this investigation.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 history lot - 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.
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.H10 additional narrative: d7a.H3, h6: part # 03.226.041.Lot # 9098264.Release to warehouse date: september 8, 2014.Manufacturer: bettlach.No ncr's were generated during production.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: CANNULATED SDDRIVE SCREWDRIVER T15
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12067319
• Report Number: 2939274-2021-03233
• Device Sequence Number: 17198258
• Product Code: HXX
• UDI-Device Identifier: 10886982077172
• UDI-Public: (01)10886982077172
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2021

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: 03.226.041
• Device Catalogue Number: 03.226.041
• Device Lot Number: 9098264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/30/2021; 09/06/2021
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 07/26/2021; 09/06/2021
• 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.