MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM CANNULATED SCREW SHORT THREAD/50MM; SCREW, FIXATION, BONE

Model Number	207.650
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device broke during removal and part of it remained in the patient; device not considered explanted.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.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 during the revision subtalar fusion and hardware removal on (b)(6) 2018, a 4mm cannulated screw short thread broke when it crossed a 6.5mm cannulated screw 32mm thread.The surgeon decided to leave the broken screw at this time.There was no surgical delay reported.The procedure was successfully completed with the patient in stable condition.Concomitant device reported: 6.5mm cannulated screw 32mm thread 80mm (part 208.438, lot unknown, quantity 1).This report is captures the intra-operative screw breakage.The need for the revision procedure is being captured on related complaint (b)(4).This is report 1 of 1 for (b)(4).

• Brand Name: 4.0MM CANNULATED SCREW SHORT THREAD/50MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7704264
• Report Number: 2939274-2018-52983
• Device Sequence Number: 10945898
• Product Code: HWC
• UDI-Device Identifier: 10886982148292
• UDI-Public: (01)10886982148292
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K963192
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2018

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 Model Number: 207.650
• Device Catalogue Number: 207.650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 07/19/2018
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 71