MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/55MM; SCREW, FIXATION, BONE

Model Number	216.055
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis.It is unknown when the non-union occurred.Original implant date is unknown.Device is not available for return.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.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 the patient had hardware removal and revision surgery performed on (b)(6) 2017, due to non-union.The patient originally had an ankle fusion performed on an unknown date and was implanted with one (1) 6.5 mm cancellous bone screw 16 mm thread for 45 mm, two (2) cancellous bone screws 16 mm thread for 50 mm, three (3) cancellous bone screws 16 mm thread for 55 mm and one (1) cannulated cancellous screw 16 mm thread 65 mm.On (b)(6) 2017, the patient was discovered to have a non-union and all the originally implanted constructs were removed fully intact.The patient was revised to two (2) one-third tubular plates and three (3) cortex screws.The procedure was completed uneventfully with no surgical delay.No additional medical intervention was required to complete the procedure and the patient was doing well post-operatively.(b)(4).

• Brand Name: 6.5MM CANCELLOUS BONE SCREW 16MM THREAD/55MM
• 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: 7160890
• Report Number: 2939274-2018-50048
• Device Sequence Number: 1497849
• Product Code: HWC
• UDI-Device Identifier: 10886982155221
• UDI-Public: (01)10886982155221(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 216.055
• Device Catalogue Number: 216.055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 72