MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT/300MM CALIB; PIN,FIXATION,SMOOTH

Model Number	900.726
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
It was reported that on an unknown date, it was noticed that the threaded guide wire was defective and bent.It is unknown if there was patient involvement.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
Additional 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.Additional narrative: additional product codes: hwc, hrs, jdw.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.
Additional 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, this complaint (b)(4) is confirmed to be a duplicate of (b)(4) initial and follow-up mw's are for retraction on the previously reported information so the complaint can be voided as a duplicate.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 or Problem Description
2/19/2019 update: this report is for the retractions of the previous medwatch's, mwr-(b)(4) and mwr-(b)(4).(b)(4) was reviewed and confirmed to be a duplicate of (b)(4).Therefore, (b)(4) will be voided as a duplicate report.

• Brand Name: 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT/300MM CALIB
• Common Device Name: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8341425
• Report Number: 2939274-2019-56467
• Device Sequence Number: 19267483
• Product Code: HTW
• UDI-Device Identifier: 10886982256362
• UDI-Public: (01)10886982256362
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K982222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2019

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
• Operator of Device: Health Professional
• Device Model Number: 900.726
• Device Catalogue Number: 900.726
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/14/2019; 02/19/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 02/15/2019; 02/19/2019
• Patient Sequence Number: 1