MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM LCP(TM) PLATE 8 HOLES/76MM; PLATE, FIXATION, BONE

Model Number	247.372
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 a hardware removal and revision of one (1) 2.7 mm locking compression (lcp) plate and six (6) 2.7 mm cortical screws was performed on (b)(6) 2017 upon discovering a non-union.The patient was implanted with a 2.7 mm lcp plate and six 2.7 mm cortical screws for an ulna shortening procedure on an unknown date.The patient was later discovered to have a non-union following the initial surgery, due to which, open reduction internal fixation was performed on (b)(6) 2017 and the originally implanted constructs were removed.The lcp plate and the cortical screws were removed and the patient was revised to a new lcp plate.The surgery was completed successfully and uneventfully with no surgical delay.The patient outcome was fine.This is report 1 of 1 for (b)(4).

• Brand Name: 2.7MM LCP(TM) PLATE 8 HOLES/76MM
• 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: 7119812
• Report Number: 2939274-2017-50283
• Device Sequence Number: 10988065
• Product Code: HRS
• UDI-Device Identifier: 10886982170873
• UDI-Public: (01)10886982170873(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063049
• 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): 11/15/2017

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: 247.372
• Device Catalogue Number: 247.372
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2017
• 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: 53 YR