MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM TI VAL STRAIGHT PLATE 12 HOLES; PLATE, FIXATION, BONE

Model Number	04.130.251
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: patient¿s information is not available for reporting.Date of event is unknown.(b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 the patient was implanted with a 1.5 variable angle (va) locking plate on an unknown date.Due to tissue closure issues, the 1.5 va locking plate was removed.It was not reported if there was a surgical delay.The patient outcome is unknown.There is no other information available at this time.(b)(4).
Additional Manufacturer Narrative
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
Further it was reported that initially the patient was implanted with a 1.5 variable angle (va) locking plate on an unknown date for a first metacarpal fracture.On (b)(6) 2018, the patient underwent a removal surgery to remove the locking plate and five screws due to tissue closure issues.It was also reported that the fracture did heal but the surgical wound did not.It was unknown if there was an infection and it was also unknown if cultures were obtained.The plate was removed successfully and the surgery was also completed successfully as reported with no further patient intervention.Concomitant device/s reported: unknown locking screw (unknown part #, unknown lot #, qty 5).

• Brand Name: 1.5MM TI VAL STRAIGHT PLATE 12 HOLES
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7378573
• Report Number: 2939274-2018-51276
• Device Sequence Number: 1456186
• Product Code: HRS
• UDI-Device Identifier: 10886982112880
• UDI-Public: (01)10886982112880(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K141527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2018

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: 04.130.251
• Device Catalogue Number: 04.130.251
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 04/02/2018
• 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