MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL; TAP, BONE

Model Number 310.95

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

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 (b)(6) 2020, during fracture repair, the handle with mini quick coupling was missing a piece.It was noticed when the surgeon is unable to unscrew an unknown screw that had already been placed.It was completed the surgeons used an alternative screwdriver handle.The reason for removal of the screw was unknown "kely" due to an issue with screw length.There was no surgical delay.There was no patient consequence.Concomitant device reported: screw: trauma (part number unknown, lot unknown, quantity 1).Screwdrivers: trauma (part number unknown, lot unknown, quantity 1).This report involves one (1) handle with mini quick coupling, stainless steel.This is report 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.H10 additional narrative: b4: alert date updated to (b)(6) 2020 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: the handle with mini quick coupling, stainless steel (product code: 310.95, lot number: 2092) was received.It was observed that the slotted setscrew component was missing.Functional testing: the sleeve was moving as intended.The mating device was not received.Unable to perform complete functional test.Document/specification review: relevant oldest drawing reviewed.Dimension inspection: its not relevant to the missing component conclusion: the complaint is confirmed for missing but could not be confirmed for the unable to assemble.A definitive assignable root cause could not be determined based on the provided information.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.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 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

Product complaint #(b)(4).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.Investigation summary: background: (b)(6) 2020: updated event description to capture concomitant device based on note-a-5010269: it was reported that on (b)(6) 2020, during an unknown operation, the handle with mini quick coupling was missing a piece.It was noticed when the surgeon is unable to unscrew an unknown screw that had already been placed.It was completed the surgeons used an alternative screwdriver handle.There was no surgical delay.There was no patient consequence.Concomitant device reported: unknown screw: trauma (part# unknown, lot# unknown, quantity 1) unknown screwdrivers: trauma (part# unknown, lot# unknown, quantity 1) this complaint involves one (1) device.H3, h4, h6:device history lot.Product code: 310.95.Lot number: 2092.Dhr not available as device is older than 22 years.At this time the manufacturing documents for instruments had to be stored for 10 years.This was according to se_075477 (filing and archiving of specification documents) version ai, which was in place till august 2014.Oldest in erp system documented lot is 2112 which was manufactured in january 1998.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided in the attachment(s) ¿(b)(4) ra pending email¿.The images were reviewed, and the complaint condition could be confirmed, as it was observed that the slotted setscrew component was missing from the received pictures.However, the device interaction issue can not be confirmed as the device was not returned and no functional test can be performed.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.H6: service and repair evaluation: the customer reported that the issue was a missing component.The repair technician reported the screw nut was missing.Missing parts is the reason for repair.The cause of the issue is unknown.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The device was not serviceable and will be scrapped.The evaluation was confirmed.A definitive assignable root cause could not be determined based on the provided information.There is no indication that a design or manufacturing issue contributed to the complaint as the circumstances during the time of the event are unknown.No new malfunctions were observed during this investigation (based on the images) that may have contributed to the complaint condition.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 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.B4: awareness date updated to 12/19/2020.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: HANDLE WITH MINI QUICK COUPLING, STAINLESS STEEL
• Type of Device: TAP, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11139609
• MDR Text Key: 225807073
• Report Number: 2939274-2021-00115
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 10886982187147
• UDI-Public: (01)10886982187147
• 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,Followup,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 310.95
• Device Catalogue Number: 310.95
• Device Lot Number: 2092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2020
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - SCREWDRIVERS; UNK - SCREWS: TRAUMA; UNK - SCREWDRIVERS.; UNK - SCREWS: TRAUMA.