MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM BROAD LC-DCP PLATE 12 HOLES/214MM; PLATE,FIXATION,BONE

Model Number	226.62
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).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 on an unknown date, the patient experienced post-op nonunion and underwent hardware removal.On (b)(6) 2020 the surgeon performed a bone graft harvest from the left femur to bone graft a left humeral shaft non-union.The surgeon removed a 12 hole 4.5 lc-dcp broad plate and 12 cortex screws from the non-union site and then used the ria 2 system on the left femur to harvest bone graft.The surgeon entered the reamer head into the femoral canal and resistance occurred in the proximal third femoral canal.The surgeon retracted the reamer head and then advanced it several times and on the last retraction noticed the reamer head had come off of the drive shaft for reamer irrigator aspirator (ria 2).The doctor was able to retrieve the reamer head and noticed that three fragments from the reamer head had broken off.The surgeon was able to retrieve two of the fragments, but one fragment remained in the soft tissue.Once the two fragments were removed, he used the ria system with a 12mm head to complete the bone harvest.The surgeon then implanted a 12 hole 4.5 lcp broad plate and the harvested bone graft to the humerus.The drive shaft was difficult to remove from the tube assembly after the ria 2 was used.The reaming rod seal was noticed to be cracked.The procedure was successfully completed with a 60 minute surgical delay.There was patient consequence.This product complaint, (b)(4) is related to (b)(4).(b)(4) captures the nonunion event postoperatively while (b)(4) captures the reamer head that came off of the drive shaft during the hardware removal intraoperatively.This (b)(4) captures 10 out of the 13 devices while (b)(4) captures the other 3 devices.Concomitant devices reported: screws: cortex (part number unknown, lot unknown, quantity 12).This report involves 1 4.5mm broad lc-dcp® plate 12 holes/214mm.This is report 1 of 10 for (b)(4).

• Brand Name: 4.5MM BROAD LC-DCP PLATE 12 HOLES/214MM
• 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: 10188616
• Report Number: 2939274-2020-02948
• Device Sequence Number: 908115
• Product Code: HRS
• UDI-Device Identifier: 10886982159144
• UDI-Public: (01)10886982159144
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: 226.62
• Device Catalogue Number: 226.62
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 06/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: CORTEX
• Outcome Attributed to Adverse Event: Required Intervention