MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SHAFT FOR 90 SCREWDRIVER; DRILL, BONE, POWERED

Model Number 03.505.006

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2022

Event Type  malfunction  

Event Description

It was reported that on unknown date, during inspection items are found to be broken.There was no patient involvement.This report involves one (1) driveshaft for screwdriver 90°.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Only event year is known.(b)(4).Reporter is a synthes employee.The device has been 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.

Manufacturer Narrative

Only event year is known.(b)(4).Reporter is a synthes employee.The device has been 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 Description

It was reported that on unknown date, during inspection items are found to be broken.There was no patient involvement.This report involves one (1) driveshaft for screwdriver 90°.This is report 1 of 2 for (b)(4).

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.Lot and expiration date part: 03.505.003 lot: 8190939 manufacturing site: selzach supplier: diener ag precision machining release to warehouse date: july 11, 2019 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the shaft for 90 screwdriver was returned and received for analysis.Upon visual inspection, the ball bearing is missing from the proximal end of the device.Device failure/defect identified? yes dimensional inspection: the diameter of the proximal end was measured to be within the specification.The diameter of the shaft was measured to be within the specification.The length of the device was measured to be within the specification.Document/specification review: shaft complete current and manufactured revision shaft f/screwdriver 90° current and manufactured revision general tolerancing and dimensioning document complaint confirmed: yes, the complaint can be confirmed based on the available information.Investigation conclusion: the reported condition of the complaint device (shaft for 90 screwdriver) is confirmed, the ball bearing is missing.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.D1 additional device product codes: dzj and hxx.D4: catalog and udi.

• Brand Name: SHAFT FOR 90 SCREWDRIVER
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK OBERD MASCH& KASS (CH); eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13424031
• MDR Text Key: 286116416
• Report Number: 2939274-2022-00327
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587013329
• UDI-Public: (01)10887587013329
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.505.006
• Device Catalogue Number: 03.505.003
• Device Lot Number: 8190939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1