MAUDE Adverse Event Report: SYNTHES RARON 2.4/2.7MM VA-LOCKING STRAIGHT FUSION PLATE/4-HOLE; PLATE, FIXATION, BONE

Catalog Number	02.211.263
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient height reported as (b)(6).Exact weight reported as (b)(6).Additional product code: hwc.Exact implant date is unknown; reported as six week prior to revision procedure on (b)(6) 2017.Manufacturing location: (b)(4).Manufacturing date: may 27, 2013.No non-conformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 of the right first metatarsophalangeal joint (mtpj) fusion was performed on (b)(6) 2017 due to failed hardware and non-union.A fusion of the first mtpj was performed on an unknown date six weeks prior due to arthritis.Subsequently, when the patient returned for a four week follow-up with the surgeon, it was discovered via x-ray that there was a non-union at the mtpj site and that the variable angle (va) forefoot/midfoot plate had broken on the proximal side through one of the va locking screw holes.The surgeon commented that the patient had been compliant with postoperative weight-bearing restrictions, is not obese and has no other medical issues.Removed hardware included one broken plate, four intact locking screws from the plate, and one intact 2.7mm cortical screw ¿which was previously implanted independently as part of the original construct.The removal went smoothly and without incident.No fragments were involved; the broken plate was removed easily.No reported surgical delay and no additional x-rays were required.Mtp reamers were used to get good quality bone.Cultures were taken at the operative site to rule out infection.The revision construct included one mtp fusion plate and screws, and a new independent lag screw across the joint.The procedure was completed successfully with the patient in stable condition.Concomitant devices: 2.7mm, 14x1 locking screw (part/lot unknown, quantity 1), 2.7mm, 16x1 locking screw (part/lot unknown, quantity 1), 2.7mm, 18x1 locking screw (part/lot unknown, quantity 1), 2.7mm, 18x1 cortex screw (part/lot unknown, quantity 1), 2.7mm and 34x1 cortex screw (part/lot unknown, quantity 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was performed on the returned subject device.A visual inspection under 5x magnification, dimensional inspection of features related to this complaint, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.The 2.4/2.7mm va-locking straight fusion plate/4-hole was received at customer quality (cq) in two pieces.The transverse break occurred on the right edge of the 2nd of four combi-holes.The material composition at the location of breakage appears homogeneous when viewed under 5x magnification.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned plate is already broken.The following parts were returned as concomitant devices without an alleged complaint condition.Upon visual inspection there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on these devices: 2.7mm, 14x1 locking screw (quantity 1), 2.7mm, 16x1 locking screw (quantity 1), 2.7mm, 18x1 locking screw (quantity 1), 2.7mm,18x1 cortex screw (quantity 1), 2.7mm and 34x1 cortex screw (quantity 1).No new malfunctions were identified as a result of the investigation.The plate thickness and width at the location of breakage measured and is within specification per relevant drawing.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The break is consistent with the result of excessive shear forces.When there is insufficient reduction or healing is delayed there are increased loads the implant must withstand, that would normally be supported by the bone, which could eventually cause it to break due to metal fatigue.This is further impacted by patient¿s compliance and activity level, comorbidities, and the surgical technique.Thus, since the specific conditions at the time of the break are unknown, the root cause cannot be definitively determined.No new, unique or different patient harms were identified as a result of this evaluation.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.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: 2.4/2.7MM VA-LOCKING STRAIGHT FUSION PLATE/4-HOLE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH394 2; SZ CH3942
• MDR Report Key: 6421602
• Report Number: 3006126083-2017-10015
• Device Sequence Number: 16338605
• Product Code: HRS
• UDI-Device Identifier: 10886982054722
• UDI-Public: (01)10886982054722(10)8382479
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

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 Catalogue Number: 02.211.263
• Device Lot Number: 8382479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/24/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1 UNKNOWN 2.7MM AND 34X1 CORTEX SCREW; 1 UNKNOWN 2.7MM, 14X1 LOCKING SCREW; 1 UNKNOWN 2.7MM, 16X1 LOCKING SCREW; 1 UNKNOWN 2.7MM, 18X1 CORTEX SCREW; 1 UNKNOWN 2.7MM, 18X1 LOCKING SCREW
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 50