MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; NAIL, FIXATION, BONE

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Unknown when device actually malfunctioned.Device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.This report is for unknown unk/guide/compression/k-wire/unknown lot number.510k#: unknown.Without a lot number the device history records review could not be conducted due the insufficient information.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate.

Event Description

It was reported that k-wires are getting stuck on an insertion guide, and the tip of an inter-lock screwdriver is damaged/bent.There was no procedure involvement.No other additional information provided.This complaint involves two (2) devices.This report is 2 of 2 for (b)(4).

Event Description

The initial complaint was reviewed and found not reportable.It was reported that the k-wire gets stuck in the insertion guide.The complaint is a non-reportable malfunction with no reported patient harm.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.

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.The initial complaint was reviewed and found not reportable.It was reported that the k-wire gets stuck in the insertion guide.The complaint is a non-reportable malfunction with no reported patient harm.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.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.

• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7533685
• MDR Text Key: 108910778
• Report Number: 2939274-2018-52256
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1