MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WRIST FUSION PLATE 8 HOLES/STANDARD; APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM

Model Number 242.510

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of postoperative plate breakage and nonunion, infection development is unknown.Originally implanted on an unknown date of (b)(6) 2014.Complainant device is not expected to be returned for manufacturer review/investigation.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 Description

It was reported that a patient underwent a hardware removal and revision on (b)(6) 2017 due to broken wrist fusion plate, nonunion and infection.Hardware was originally implanted on an unknown date of (b)(6) 2014.The patient is reported to have presented to the surgeon with a broken plate, thus leading to the hardware removal being scheduled.The surgeon removed one (1) wrist fusion plate, one (1) distal radial plate, seven (7) 2.7 mm cortex screws and three (3) 3.5 mm cortex screws, and replaced the hardware with a k-wire fixation including an unknown quantity of k-wires and an antibiotic cement for infection.It was also reported that fragments were generated from the broken wrist fusion plate and were retained in the patient.Procedure was completed successfully without any surgical delay.Patient¿s outcome reported as okay.This report is for one (1) wrist fusion plate 8 holes/standard.(b)(4).

Manufacturer Narrative

Additional narrative: a device history record (dhr) review was performed for part # 242.510, lot # 7597699: part manufacture date: 18-mar-2014, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a: dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of wrist fusion plate 8 holes/standard product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.No product was returned.Us cq conducted the investigation based on x-ray provided.X-ray showed the plate was broken.This complaint is confirmed.Since the x-ray was taken pre-operatively of the revision surgery, embedded pieces could not be confirmed.Whether this complaint could be replicated is not applicable because the device was not returned.While no definitive root cause could be determined it is possible that the implant experienced unintended loads prior to the bones healing.Relevant drawing was reviewed and were determined to be suitable for the intended design, application and dimensional conformity when used as recommended.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition therefor no further corrective and preventive actions are proposed.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: WRIST FUSION PLATE 8 HOLES/STANDARD
• Type of Device: APPLIANCES,FIXATION,NAIL/BLD/ PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7083522
• MDR Text Key: 93751608
• Report Number: 3003506883-2017-50004
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 10886982168696
• UDI-Public: (01)10886982168696(10)7597699
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2017

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
• Device Operator: Health Professional
• Device Model Number: 242.510
• Device Catalogue Number: 242.510
• Device Lot Number: 7597699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 12/05/2017
• Supplement Dates Manufacturer Received: 01/04/2018
• Supplement Dates FDA Received: 01/05/2018
• Date Device Manufactured: 03/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 66