MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SMALL HEXAGONAL SCREWDRIVER SHAFT; SCREWDRIVERS

Model Number 314.03

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.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 (b)(6) 2019, the small hexagonal screwdriver shaft is not fitting into stryker power drill quick connect attachment.Opened an additional small fragment set.There was a surgical delay of one (1) minute.Procedure was successfully completed.Patient outcome was as planned.Concomitant device reported: stryker power drill (part #: unknown, lot #: unknown, quantity #: 1).This complaint if for one (1) small hexagonal screwdriver shaft.This report is 1 of 1 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.Additional narrative: device manufacture date corrected data: mfr site.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

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.Additional narrative: the small hexagonal screwdriver shaft was received with minimal signs of wear on the device.A functional test could not be completed since the shaft was returned by itself.The complaint was not able to be replicated.Therefore, the complaint is not confirmed.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.No new malfunctions were observed during the course of 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, part: 314.030, lot: 7729899, manufacturing site: hägendorf, release to warehouse date: (b)(6)2012.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: SMALL HEXAGONAL SCREWDRIVER SHAFT
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8542063
• MDR Text Key: 142884980
• Report Number: 2939274-2019-57611
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188380
• UDI-Public: (01)10886982188380
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/28/2019

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
• Device Operator: Health Professional
• Device Model Number: 314.03
• Device Catalogue Number: 314.03
• Device Lot Number: 7729899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/23/2019
• Supplement Dates Manufacturer Received: 05/14/2019; 05/14/2019
• Supplement Dates FDA Received: 05/24/2019; 05/24/2019
• Patient Sequence Number: 1
• Treatment: SEE EVENT DESCRIPTION.
• Patient Age: 16 YR