MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC POSITIONING DEVICE FOR GUIDING BLOCK; GUIDE

Catalog Number	03.108.006
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Date of event: unknown.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6) 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.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 (b)(4) reports an event in (b)(6) as follows: it was reported that during a pediatric hip osteotomy procedure, the guide block positioner would not slide onto the aiming/ guiding block correctly, and in turn, would not allow the guide wire to be placed in the proper location.The nurse finally hammered the positioner onto the aiming block, and the surgery was completed successfully.There was no reported surgical delay, no fragments were generated, and there was no reported harm to the patient.This report is for one (1) positioning device for guiding block.This is report 1 of 2 for (b)(4).

• Brand Name: POSITIONING DEVICE FOR GUIDING BLOCK
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7271121
• Report Number: 2939274-2018-50635
• Device Sequence Number: 13888652
• Product Code: FZX
• UDI-Device Identifier: 10886982071569
• UDI-Public: (01)10886982071569(10)LOTUNKNOWN
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 03.108.006
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1