MAUDE Adverse Event Report: SYNTHES MONUMENT 2.4/2.7MM TI VA-LCP CLOVERLEAFFUSION PLATE/LONG; PLATE, FIXATION, BONE

Catalog Number	04.211.252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient weight is not available for reporting.Additional device product code is hwc.(b)(6).The subject device has been received and is currently in the evaluation process.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: apr 15, 2011.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The final product met specification and inspection acceptance criteria.No non-conformances were generated during the production of the subject device.(b)(4).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 the patient underwent revision surgery on (b)(6) 2017 for a nonunion and a broken titanium (ti) variable angle (va) - locking compression plate (lcp) cloverleaf long fusion plate at her 2nd metatarsal.She was initially implanted on (b)(6) 2016 with two, 3.5 mm cannulated screws at the 1st metatarsal, one ti va-lcp cloverleaf long fusion plate at the 2nd metatarsal, and one ti va-lcp cloverleaf standard fusion plate at the 3rd metatarsal with approximately eleven screws between the two plates (three 2.7 mm cortical screw and eight 2.7 mm locking screws).During a follow-up visit on unknown date, the patient complained of pain at the 1st and 2nd metatarsal.X-rays were taken and revealed the nonunion and that the ti va-lcp cloverleaf long fusion plate broke at the first combihole.It was reported that there was no screw implanted where the plate broke.It was also noticed during the visit that one of the 3.5 mm cannulated screws at the 1st metatarsal was protruding.It was reported that the surgeon felt the patient was non-compliant.During the procedure, all hardware was easily removed and intact with the exception of the known broken plate.It was reported that all fragments were retrieved.The surgeon implanted a ti va-lcp cloverleaf standard fusion plate, one cortex screw, and four locking screws along with a competitor¿s bone graft at the 2nd metatarsal.It was reported that since the patient had healed at the 1st and 3rd metatarsal, no new devices were implanted.The surgery was completed successfully without delay, and the patient was stable.Concomitant devices: 2.4/2.7 mm ti va-lcp cloverleaf fusion plate/standard (part #04.211.251, lot #6652326, quantity 1), 2.7 mm locking screws (quantity 4), 2.7 mm ti cortex screw (part #402.872, lot #2770533, quantity 1) 2.7 mm ti cortex screw (part #402.880, lot #7746631, quantity 1), 2.7 mm ti cortex screw (part #402.872, lot #2651821, quantity 1), washer (quantity 2) and 3.5 mm cannulated screws ( quantity 1).This report is 1 of 1(b)(4).
Additional Manufacturer Narrative
(b)(6).A product development investigation was performed.The following devices were received at customer quality (cq) for evaluation: one (1) 2.4/2.7mm ti va-lcp plate (part# 04.211.252; lot# 6632254); complaint category ¿ broken: postoperatively and one unk screw - cannulated (part# unk; lot# unk); complaint category ¿ implant failure postoperatively: migrated.The following concomitant devices were returned without allegation.The implants were examined and no defects or deficiencies were identified which may have contributed to the reported complaint condition.No further investigation, including drawing review, complaint history review and occurrence rate calculation will be completed: one 2.4/2.7mm ti va-lcp cloverleaf fusion plate/standard (part# 04.211.251; lot# 6652326), eight 2.7mm locking screws (part# unk; lot# unk), one 3.5mm cannulated screw (part# unk; lot# unk), one cortical screw (part# 402.872; lot# 2770533), one cortical screw (part# 402.880; lot# 7746631), one cortical screw (part# 402.872; lot# 2651821), two washers (part# unk; lot# unk) a visual inspection, functional test, dcrm review, device history review, and drawing review were performed as part of this investigation.The complaint conditioned is confirmed, as the 2.4/2.7mm ti va-lcp cloverleaffusion plate/long was returned in broken condition.The complaint condition cannot be confirmed or replicated as implant failure postoperatively: migrated.Other clinical factors such as the patient¿s condition or early excessive mobilization and loading of the implant could have impacted the construct postoperatively.Eight returned, concomitant locking screws were examined and four were found to have minor thread damage in the middle of the threads, that likely occurred on implantation/explantation.As there was no damage at the screw-plate interface, it can be reasonable stated that they did not contribute to the complaint condition.The remaining concomitant devices were also visually inspected and no defects or deficiencies which may have contributed to the complaint condition were identified.The complaint condition was most likely caused by early excessive mobilization and loading of the implant.However, the specific conditions at the time of postoperative failure are unknown, so a root cause is indeterminable.It is not likely that the design of the instrument contributed to this complaint.No new, unique or different patient harms were identified as a result of this evaluation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 TI VA-LCP CLOVERLEAFFUSION PLATE/LONG
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6555320
• Report Number: 1719045-2017-10442
• Device Sequence Number: 1149431
• Product Code: HRS
• UDI-Device Identifier: 10886982119919
• UDI-Public: (01)10886982119919(10)6632254
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 04/11/2017

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: 04.211.252
• Device Lot Number: 6632254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 06/06/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 402.872, 2.7MM TI CORTEX SCREW, QTY. 2; 402.880, 2.7MM TI CORTEX SCREW, QTY.1; UNKNOWN WASHER, QTY. 2; UNKNOWN, 2.7MM LOCKING SCREWS, QTY. 4; UNKNOWN, 3.5MM CANNULATED SCREWS, QTY. 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 61