MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/49MM; PLATE, FIXATION, BONE

Model Number	241.34
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Irritation (1941); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown when the tissue irritation began.Complainant part is not expected to be returned for manufacturer review/investigation.Device history record: manufacturing location: (b)(4).Raw material for (b)(4) inspection certificate meet specification.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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 a hardware removal surgery was performed on (b)(6) 2017 to remove a one-third tubular plate with collar 4 holes/49mm, a locking compression plate one-third tubular plate with collar 7 holes/81mm, eight (4.0mm) cancellous screws, and three (3.5mm) cortex screws.The initial surgery date is unknown but it was for a fibula fracture.The hardware removal was due to soft tissue irritation.There were no malfunctions with the hardware removed, no surgical delays and the surgery was completed successfully with patient outcome noted as stable.X-rays were taken but unavailable to be sent.No additional implants or medical interventions were performed on patient post hardware removal.This complaint involves 13 parts.This report is 1 of 4 for (b)(4).

• Brand Name: ONE-THIRD TUBULAR PLATE WITH COLLAR 4 HOLES/49MM
• 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: 7119034
• Report Number: 2939274-2017-50269
• Device Sequence Number: 13771190
• Product Code: HRS
• UDI-Device Identifier: 10886982166821
• UDI-Public: (01)10886982166821(10)3149637
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 241.34
• Device Catalogue Number: 241.34
• Device Lot Number: 3149637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/14/2017
• 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: 43 YR