MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI PROXIMAL EXTENSION SIZE 6/500MM RADIUS; PROSTHESIS, RIB REPLACEMENT

Model Number 04.641.056

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 11/17/2019

Event Type  Injury  

Manufacturer Narrative

Reporter is a synthes employee.Part number: 04.641.056, lot number: 7775087, per jde, manufactured date: 09/09/2014.A manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4) no manufacturing record evaluation is required.Visual inspection: the proximal extension (p/n:04.641.056, lot #:7775087) was returned and received assembled with titanium distal extension size 6/500mm radius (p/n: 04.641.076) and titanium distraction lock (497.125) at us customer quality.Upon visual inspection, it was observed that the proximal side of the proximal extension where the ti distraction lock was supposed to be right with ti distal extension when connected was broken causing the proximal extension to articulate.There were nicks and scratches on the device which could be due to explanation and has no impact on the functionality of the device.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed: proximal extension veptr ii.Complaint confirmed? yes, the device received is broken.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed for the proximal extension (p/n:04.641.056, lot #:7775087) is broken, which could have contributed to the complaint condition.There is no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.(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 Description

It was reported that on (b)(6) 2019 that the patient underwent the removal of an adaptor.When the surgeon removed the proximal distal rod articulate, where the connection is made that is supposed to be rigid, the parallel connector was not holding the rod.Patient status and outcome were unknown.Concomitant devices: titanium (ti) distal extension size 6/500mm radius (part: 04.641.076, lot: 9953122, quantity: 1) ti distraction lock (part: 497.125, lot: h688156, quantity: 1).This report is for one (1) ti proximal extension size 6/500mm radius.This is report 2 of 2 for (b)(4).

• Brand Name: TI PROXIMAL EXTENSION SIZE 6/500MM RADIUS
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9601614
• MDR Text Key: 189479290
• Report Number: 2939274-2020-00263
• Device Sequence Number: 1
• Product Code: MDI
• UDI-Device Identifier: 10705034750149
• UDI-Public: (01)10705034750149
• Combination Product (y/n): N
• PMA/PMN Number: K142587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.641.056
• Device Catalogue Number: 04.641.056
• Device Lot Number: 7775087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR