MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES/117MM; PLATE,FIXATION,BONE

Model Number	241.401
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of postoperative plate breakage and nonunion development is unknown.Original implant date reported as (b)(6) 2017; exact date is unknown.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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 report that the patient had original procedure in (b)(6) 2017 for treatment of an open reduction internal fixation for a right fibula fracture.Patient was implanted with one (1) locking compression one-third tubular plate with collar, and ten (10) 3.5mm locking and non-locking combination of cortex screws.On an unknown date post-operatively, patient presented with a broken plate with a non-union.The plate was reported as broken at the 4th screw hole position.The plate breakage was in the middle of the plate.All ten screws were reported in good condition.On (b)(6) 2017, surgeon removed all implants and revised the patient to a distal fibula plate and screws.It was reported that no fragments were generated during implant removal.Implants will be returned for evaluation.Revision surgery was completed successfully with no time delay.Patient is reported in stable condition.Sales consultant has no more information to report on this event.Concomitant device reported: unknown locking screws (item number unknown, lot number unknown, quantity 5), unknown cortex screws (item number unknown, lot number unknown, quantity 6).This report is for one (1) lcp one-third tubular plate with collar.This is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part # 241.401, lot number: h311689, part manufacture date: 04-mar-2017, 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 lcp one-third tubular plate with collar 10 holes/117mm 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.A product investigation was performed.The returned device was examined and the complaint condition was able to be confirmed as the plate was received broken through the fifth hole; additionally, the plate was bent through the seventh hole.No root cause was able to be determined with the provided information.Relevant drawings for the returned device were reviewed (both current revision and from the time of manufacture).The design, materials and finishing processes were found to be appropriate for the intended use of this device.No dimensional analysis is possible due to post-manufacturing damage.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: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 10 HOLES/117MM
• 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: 7118260
• Report Number: 2939274-2017-50276
• Device Sequence Number: 16368701
• Product Code: HRS
• UDI-Device Identifier: 10886982166951
• UDI-Public: (01)10886982166951(10)H311689
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K011335
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 241.401
• Device Catalogue Number: 241.401
• Device Lot Number: H311689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2017
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 01/10/2018
• 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
• Patient Weight: 70