MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCRDRIVER T25 SELF-HOLDING L290; SCREWDRIVER

Catalog Number	314.118
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: initial reporter is syntheses sales representative 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 unknown date, during routine incoming inspection of a loaner set, it was observed that the sddrive screwdriver was broken.There was no known patient or hospital involvement.This report is for one (1) scrdriver t25 self-holding l290 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.Part # 314.118.Synthes lot # 6646211.Release to warehouse date: april 25, 2011.Manufacturing location: jennersville.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 scrdriver t25 self-holding l290 (p/n: 314.118, lot #: 6646211) was returned for analysis.Visual inspection of the returned device did not found a broken condition.However, a crack was identified on the handle of the instrument.Device failure/defect identified? yes dimensional inspection: dimensional inspection cannot be performed due to post manufacturing damage.Document/specification review: current and manufactured revisions.Complaint confirmed: yes, complaint can be confirmed based on the available information.Investigation conclusion: the reported condition of the complaint device (scrdriver t25 self-holding l290) is confirmed.Device is cracked.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: SCRDRIVER T25 SELF-HOLDING L290
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13392508
• Report Number: 2939274-2022-00293
• Device Sequence Number: 17150172
• Product Code: HXX
• UDI-Device Identifier: 07611819775169
• UDI-Public: (01)07611819775169
• Combination Product (Y/N): N
• 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 Catalogue Number: 314.118
• Device Lot Number: 6646211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• 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: 02/11/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2011
• 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