MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT; SCREWDRIVERS

Model Number	314.23
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: reporter is a j&j representative.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 that on an unknown date while inspecting the instruments after going through the decontamination process, i noticed that one synthes cannulated hexagonal screwdriver shaft was damaged.The tip of the power shaft was completely break off.It was unknown that when the damaged occurred.There was no patient involvement.This complaint involves one (1) device.This report is for (1) cannulated 4.0 hexagonal screwdriver sft.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.D4 h3, h4, h6: part # 314.23.Synthes lot # a4ge678.Supplier lot # na.Release to warehouse date: 18 jun 1997.Manufactured by synthes exton.No ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the cannulated 4.0 hexagonal screwdriver sft (part #: 314.23, lot #: a4ge678) was received at us customer quality (cq).Upon visual inspection, the hexagonal tip of the device has broken off.Surface scratches were also noticed.Device failure/defect identified? yes.Dimensional inspection: measured dimensions: distal shaft od = conforming.Middle shaft od = conforming.Document/specification review: (current) and (manufactured) were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the distal hexagonal tip of the complaint device has broken off.No definitive root cause could be determined based on the provided information.No new, unique or different patient harms were identified as a result of this evaluation.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 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: CANNULATED 4.0 HEXAGONAL SCREWDRIVER SFT
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12384047
• Report Number: 2939274-2021-04988
• Device Sequence Number: 3673357
• Product Code: HXX
• UDI-Device Identifier: 10886982188700
• UDI-Public: (01)10886982188700
• 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
• Report Date (Section B): 08/02/2021

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: 314.23
• Device Catalogue Number: 314.23
• Device Lot Number: A4GE678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 09/27/2021
• Patient Sequence Number: 1