MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC COMPRESSION SLEEVE FOR 2.4MM HEADLESS COMPRESSION SCREW; GUIDE

Catalog Number	03.226.016
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter: synthes sales representative.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary - product was not returned.Based on the information available, it has been determined that no corrective and 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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, a headless compression screw, short thread was not twisting well in the compression sleeve during an unknown surgery.It is unknown if there was surgical delay.Patient and procedure outcome is unknown.This complaint involves two (2) devices.This report is one (1) compression sleeve for 2.4mm headless compression screw.This report is 2 of 2 for (b)(4).

• Brand Name: COMPRESSION SLEEVE FOR 2.4MM HEADLESS COMPRESSION SCREW
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8262891
• Report Number: 2939274-2019-55966
• Device Sequence Number: 19353040
• Product Code: FZX
• UDI-Device Identifier: 07611819991668
• UDI-Public: (01)07611819991668
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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: 03.226.016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 01/18/2019
• Patient Sequence Number: 1