MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM

Catalog Number	03.010.082
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a guide wire got stuck inside the wire guide.Wire guide does not self-center the wire anymore.This complaint involves two (2) devices.This report is for one (1) drillsl 13/3.2 f/03.010.081 yell.This report is 2 of 2 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.H3, h6: the received picture was reviewed, there is a segment of a sleeve with part number 03.010.082 and lot number 3384830 visible.The complained functional issue cannot be confirmed based on the picture.Product was not returned, therefore no further investigation is possible.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.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Event date: a device history record (dhr) review was conducted: part number: 03.010.082 synthes lot number: 3384830 manufacturing site: hägendorf release to warehouse date: 03.March 2010 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Exact date is unknown date of report.Pma/510k: the incorrect g4 date was inadvertently utilized in initial medwatch.The correct date is (b)(6) 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.
Event or Problem Description
It was also reported that there was surgical delay of one (1) minute procedure was completed successfully by removing the wire and reinserting outside the leg before re-engaging the wire guide onto the insertion handle.There was no patient consequence.

• Brand Name: 13.0MM/3.2MM WIRE GUIDE FOR SPIRAL BLADE AIMING ARM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10121686
• Report Number: 2939274-2020-02673
• Device Sequence Number: 11301132
• Product Code: FZX
• UDI-Device Identifier: 07611819784123
• UDI-Public: (01)07611819784123
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2020

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 Catalogue Number: 03.010.082
• Device Lot Number: 3384830
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 06/23/2020; 07/06/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/24/2020; 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1