MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM GUIDE WIRE 290MM; NAIL, FIXATION, BONE

Model Number 03.010.115

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

There was no known reported patient involvement associated with the complained event.It is unknown when device malfunctioned.Additional device product code: jdw.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.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 upon receipt of order, it was discovered that a guide wire was bent and quite curved that supposed to be straight.There was no patient involvement.This report is for one (1) 3.2mm guide wire 290mm.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.The device was 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.

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.Dhr review was completed.Part number: 03.010.115 , lot number: h707729 , part manufacturing date: 27 august 2018 , manufacturing site: elmira , part expiration date: n/a , nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h707729 of 3.2mm guide wires was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h654512 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Customer quality conducted an investigation of the returned device.Device evaluation: damage: visual (appearance not as expected) visual inspection: visual inspection observed that the guide wire was deformed and bent centrally.The packaging for the guide wire was damaged and had several linear rips running parallel to the orientation of the guide wire in the package.Product was received and photographically documented at product handling as intact but the non-perforated end of the package arrived cut-off at customer quality investigations.No surface wear was observed on the guide wire which is consistent with its august 2018 manufacturing date and it being in its manufacture packaging.The received condition was determined to agree with the complaint description and therefore the complaint was confirmed.Dimensional inspection: during the document/specification review the following drawings, reflecting the current and manufactured revision, were reviewed.3.2mm drill tip guide wire length 290mm, r/afn: bags- ldpe on roll: material specification bags- ldpe on roll, 2x13in: all dimensional inspections were performed with calipers.Dimensional inspection was performed on the 3.2mm 290mm guide wire (03.010.115, h707729) and the overall length of the wire measured 288.77mm, which does not fall within specification of 290±1.2mm, based on the drawing.The undersized condition is due to the deformation of the guide wire.As for the packaging, dimensional inspection was performed to verify the degree to which the open end of the package was cut.The packaging measured 12.59 inches which still does conform to the 13±0.5 inch specification based on drawing.The cut condition was not a complaint condition as the device packaging was cut after arriving at product handling and the cut condition of the packaging did not contribute to the received condition of the device at investigation.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no ncrs, mrrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Investigation conclusion: this complaint is confirmed however no product design issues or manufacturing discrepancies were identified during this investigation.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.

• Brand Name: 3.2MM GUIDE WIRE 290MM
• 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: 7966775
• MDR Text Key: 123806416
• Report Number: 2939274-2018-54383
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982067869
• UDI-Public: (01)10886982067869
• Combination Product (y/n): N
• PMA/PMN Number: K970097
• 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: 10/01/2018

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
• Device Operator: Health Professional
• Device Model Number: 03.010.115
• Device Catalogue Number: 03.010.115
• Device Lot Number: H707729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/15/2018
• Supplement Dates Manufacturer Received: 10/23/2018; 11/26/2018
• Supplement Dates FDA Received: 11/07/2018; 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1