MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC BUTTRESS/COMPRESSION NUT FOR 357.369; APPARATUS, TRACTION, NON-POWERED

Model Number 357.371

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that the compression nut (357.69) is jammed on the sleeve (357.371).Concomitant devices: unknown nail (part # unknown, lot # unknown, quantity 1).Unknown aiming arm (part # unknown, lot # unknown, quantity 1).This report is for one (1) buttress/compression nut for 357.369.This is report 1 of 2 for (b)(4).

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.The compression nut (357.69) is jammed on the sleeve (357.371).Concomitant device reported: unknown nail (part # unknown, lot # unknown, quantity 1), unknown aiming arm (part # unknown, lot # unknown, quantity 1).This complaint involves two (2) devices.Investigation flow: visual/device interaction.Visual inspection: buttress/compr-nut f/357.369 (part# 357.371, lot# t102368, qty# 1) was returned received at us cq.Upon visual inspection at cq, it is observed that the device was stuck on guide sleeve.Few scratches were observed all over the body of the device.The lot number on the device started to fade.Functional inspection: functional inspection of the device was not performed at cq due to the received stuck condition.But the stripped external threads of the mating device (part# 357.369, lot# 79041) might have contributed to the complaint condition.The complaint was replicated with the returned device.Dimensional inspection: dimensional inspection of the device was not performed as the relevant features of the device were inaccessible due to the stuck condition.Document/ specification review: the following drawings were reviewed during the investigation: -buttress/ compression nut for blade guide sleeve, tfn: 357_371 rev.B and rev.E no design issues or discrepancies were noted during the investigation.Complaint was confirmed.Investigation conclusion: the complaint is being confirmed for buttress/compr-nut f/357.369 (part# 357.371, lot# t102368) as the device was stuck on mating guide sleeve.The stripped external threads of the mating device (part# 357.369, lot# 79041) might have contributed to the unable to disassemble condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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.

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 2 report as august 04, 2020 but should have been october 29, 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.H3, h4, h6- buttress/compr-nut f/357.369 (part# 357.371, lot# t102368, qty# 1) was returned received at us cq.Upon visual inspection at cq, it is observed that the device was stuck on guide sleeve.Few scratches were observed all over the body of the device.The lot number on the device started to fade.The complaint is being confirmed for buttress/compr-nut f/357.369 (part# 357.371, lot# t102368) as the device was stuck on mating guide sleeve.The stripped external threads of the mating device (part# 357.369, lot# 79041) might have contributed to the unable to disassemble condition.No product design or manufacturing issues were identified, and no new malfunctions were identified either.Based upon these results, 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 history lot part number:357.371, synthes lot number: 6196481, supplier lot number: t102368, release to warehouse date: 04aug2009, expiration date: n/a, supplier: (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, 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: BUTTRESS/COMPRESSION NUT FOR 357.369
• Type of Device: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10468480
• MDR Text Key: 208713292
• Report Number: 2939274-2020-03862
• Device Sequence Number: 1
• Product Code: HST
• UDI-Device Identifier: 10886982196057
• UDI-Public: 10886982196057
• 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,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 357.371
• Device Catalogue Number: 357.371
• Device Lot Number: 6196481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAILS