MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 3.5MM LCP PLATE 7 HOLES 98MM; PLATE, FIXATION, BONE

Model Number	223.571
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the event occurred.This report is for a plate - unknown lot.Additional procode hwc and ktt.Implant date: unknown.Complainant part has not been 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 for an open reduction internal fixation (orif) of a right mid-shaft humerus was performed on (b)(6) 2017 due to a broken plate and non-union.Original procedure was performed on an unknown date in (b)(6) 2017.Subsequently it was identified that the plate had broken.The plate and all screws were removed - all screws were intact.The plate broke in the center hole (7-hole plate).The non-union was treated with vivigen.No infection was present.The surgeon stated that the patient may have been non-compliant with post-operative weight bearing instructions.The procedure was completed successfully with the patient in stable condition.Concomitant device(s) reported: 3.5 mm cortex screws (part #: unknown, lot #: unknown, qty: 2) , 3.5 mm locking screws (part #: unknown, lot #: unknown, qty: 4).This complaint involves one (1) device.This is 1 of 1 for (b)(4).This report is for a plate.
Additional Manufacturer Narrative
(b)(6).Therapy date: (b)(6) 2017; exact date is unknown.Implanted on an unknown date in (b)(6) 2017.Complainant device is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 3.5MM LCP PLATE 7 HOLES 98MM
• 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: 7173156
• Report Number: 2939274-2018-50114
• Device Sequence Number: 10996145
• Product Code: HRS
• UDI-Device Identifier: 10886982157935
• UDI-Public: (01)10886982157935(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• 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,Followup
• Report Date (Section B): 12/11/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 223.571
• Device Catalogue Number: 223.571
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 02/06/2018
• 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