MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AWL 12MM

Catalog Number 03.820.100

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.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 Description

It was reported that on (b)(6) 2019, the awl broke and has a bent tip during a prodisc-c procedure.It is unknown if the tip was bent prior to procedure or while it was being used.The surgeon did not have any issues while using the device.No fragments were generated from broken device.It is unknown if there was surgical delay.Procedure was successfully completed.Patient status is unknown.This report is for one (1) awl 12mm.This is report 1 of 1 for complaint (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.H6: the instrument was not returned and instead investigation is done based on the supplied image.The image(s) (1 total) was reviewed and the complaint condition for broken intra-op for the center punch could not be confirmed as the image shows the distal end to be bent off axis and not broke and therefore will be coded as such.As the instrument was not returned an as received, dimensional, material or drawing reviews are not applicable.A review of the device history records showed that there were no issues at the time of manufacturing of this device and its sub components that would contribute to the complaint condition.No definitive root cause was able to be determined as the circumstances surrounding the complaint are unknown.During this investigation no product design or manufacturing issues were observed 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.H10 additional narrative: h3, h4, h6: device history lot: part number: 03.820.100.Synthes lot number: t121822.Release to warehouse date: 09-sep-2015.Manufacture site: tuttlingen.Part expiration date: n/a.List of non-conformance: n/a.A review of the device history records showed that there were no issues at the time of manufacturing of this device and its subcomponents that would contribute to the complaint condition.The raw material certificate was reviewed and the used material was according to the specification of the device.No ncrs were generated during the production of this device.Device history batch null, device history review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.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: AWL 12MM
• Type of Device: AWL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8298841
• MDR Text Key: 134893650
• Report Number: 2939274-2019-56263
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 10705034731360
• UDI-Public: (01)10705034731360
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.820.100
• Device Lot Number: T121822
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1