MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM; INSTRUMENT COMPRESSION

Model Number	321.12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional 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, 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 (b)(6) 2020, the articulated tension device malfunctioned and broke while being used in a case.Surgeon immediately opened another tray to use a second device that worked properly.Fragments were generated but were removed easily.There was a delay in surgery for about one (1) minute.The procedure was completed successfully.There was no patient consequence.This report is for one (1) articulated tension device with gauge-span 20mm.This is report 1 of 1 for complaint (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.H11: corrected data: g4: awareness date reported on follow up 1 report as april 23, 2020 but should have been may 14, 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.
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.H3, h4, h6 investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 history part: 321.120, lot: 1256255, manufacturing site: hägendorf, release to warehouse date: 30.June 2004.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.
Event or Problem Description
Updated event: the articulated tension device malfunctioned and broke while being used in a case.Immediately opened another tray to use a second device that worked properly.A tiny washer came off of the tensioning device and was dropped on the floor and not recovered at the end of surgery.Fragments were generated but were removed easily.There was a delay in surgery for about one (1) minute.The procedure was completed successfully.There was no patient consequence.

• Brand Name: ARTICULATED TENSION DEVICE WITH GAUGE-SPAN 20MM
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10026960
• Report Number: 2939274-2020-02262
• Device Sequence Number: 3117015
• Product Code: HWN
• UDI-Device Identifier: 10886982190369
• UDI-Public: (01)10886982190369
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2020

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: 321.12
• Device Catalogue Number: 321.12
• Device Lot Number: 1256255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 05/27/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/26/2020; 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR