MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM GUIDE WIRE 400MM; MISC ORTHO SURGICAL INSTR

Catalog Number 357.399

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient involvement reported.Date of event is unknown.Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.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 two (2) 3.2mm guide wires were noted to be bent while filling the field equipment trays.Both wires were still in the original packaging.No patient involvement reported.This report is for one (1) 3.2mm guide wire 400mm.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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

A device history record (dhr) review was conducted for part number: 357.399, lot number: h578142: part manufacturing date: 06 march 2018, manufacturing site: (b)(4), part expiration date: n/a, non-conformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h578142 of 3.2mm guide wires was processed through the normal manufacturing and inspection operations with no rework or non-conformance 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 h509619 met all specifications with no issues documented that would contribute to this complaint condition.A product investigation was conducted.The guide wire (part: 357.399, lot: h578142, mfg: 06-march-2018) was received with the reported condition of ¿visual deformed/ bent: rm.¿ at customer quality, the returned guide wire (part: 357.399lot: h578142, mfg: 06-march-2018) was inspected and the complaint was confirmed.The following investigations were performed: labeling & packaging; damage: visual (appearance not as expected): visual inspection performed at customer quality observed that guide wire was significantly bent at its distal portion.The received condition agrees with the complaint description and the complaint was confirmed.Relevant drawings for the returned device were reviewed (both current and from the time of manufacture): top-level drawing for drill tip guide wire and determined to be suitable for the intended design and application when used as recommended.A device history review 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.While no definitive root cause could be determined, it is likely that any unintended forces encountered by the device during shipping or handling could have contributed to both damaged package and bent condition of guide wire.Also based on the dhr review it was confirmed that the device was delivered out from manufacturing site without any defects.Therefore, it is likely that any unintended forces encountered by the device during transit could have contributed to this complaint condition.During the investigation, no product design or manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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 400MM
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7459258
• MDR Text Key: 107076464
• Report Number: 2939274-2018-51922
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886982196248
• UDI-Public: (01)10886982196248
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2018

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 Catalogue Number: 357.399
• Device Lot Number: H578142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 04/27/2018; 06/01/2018
• Supplement Dates FDA Received: 05/11/2018; 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1