MAUDE Adverse Event Report: SYNTHES GRENCHEN 3.5MM TI LCP® METAPHYSEAL PLATE 14 HOLES; APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM

Catalog Number 423.414

Device Problems Break (1069); Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Complaint, Ill-Defined (2331); Disability (2371)

Event Date 12/13/2014

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).(b)(4).Exact explant date is unknown but was reportedly explanted during hospitalization ((b)(6) 2014 through (b)(6) 2014) according to medical records.The subject device is not expected to be returned to the synthes manufacturer for evaluation.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report synthes europe reported an event in the (b)(6) as follows: it was reported that the patient awoke with left shoulder pain and deformity on (b)(6) 2015.The patient was admitted to the hospital and it was discovered that the patient's 3.5mm locking compression plate (lcp) was broken.The patient is unaware of having fallen or hitting anything.Further diagnosis upon admission to the hospital on (b)(6) 2014 was fracture of the lower end of the humerus.The lcp plate and associated screws were implanted on (b)(6) 2014 as part of a revision surgery to replace a non-synthes plate (implanted on (b)(6) 2015) which had loosened.Revision surgery (date unknown) was performed during the patient's hospitalization (b)(6) 2014 through (b)(6) 2014.During the revision surgery the broken lcp plate was extracted.Spongioplasty and osteosynthesis procedures were also performed.According to the medical report, the patient made reasonable peri- and post-operative progress, and follow-up monitoring found only mild elevation of inflammation parameters.At hospital discharge on (b)(6) 2015, it was noted that cardiopulmonary was compensated and afebrile, with no neurocirculatory problems.The hospital discharge diagnosis included post pseudoarthrosis of the left humerus and fracture of the lower end of the left humerus.The hospitalization was uneventful.The patient was discharged with a long shoulder cast and post-operative and follow-up instructions.It is unknown what devices, if any, where implanted during the revision surgery.It was further reported that the patient underwent nerve reconstruction during (b)(6) 2015 (date unknown) involving approximately 10cm of nerve tissue.The surgery was reported to be unsuccessful.On (b)(6) 2015 it was reported that the patient has no function of his left arm and is now disabled.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The exact date of device breakage is unknown; however, the symptom onset reportedly began on (b)(6) 2014.(b)(6).Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device 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.

Manufacturer Narrative

A manufacturing evaluation was completed: the breakage of the lcp metaphyseal plate occurred at the ninth plate hole.The golden anodized lcp metaphyseal plate 3.5 is made of pure titanium.The examination of the raw-material inspection sheet of the supplier and the manufacturing documents of the producer showed no deviation in relation to the chemical composition, microstructure and mechanical properties.The material of the implant is in compliance with the international standards for surgical implants made of pure titanium.The dimensions of the investigated lcp metaphyseal plate 3.5 (as far as measurable) were checked using a digital sliding calliper and found to be in compliance with the technical drawing of the producer and specifications.According to the device report the patient sustained an open fracture of the left shoulder and damage to an artery at mid-shoulder level, with the radial nerve completely severed, as a result of a car accident on (b)(6) 2014.In the following surgery an osteosynthesis plate of an unknown producer was implanted.The plate was replaced by means of the investigated lcp metaphyseal plate 3.5 on (b)(6) 2014 due to the loosening of the original fixation screw.At some stage the patient reported feeling pain and the breakage of the plate were found.The date of the second revision surgery to remove the broken lcp metaphyseal plate 3.5 is unknown.There was no report with respect to the aftercare of the patient.No x-ray images were provided.Based on the topography of the fracture surface, it is likely that the implant was subjected to moderate dynamic bending loads.Constant load cycles led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the plate.The implant could not resist the applied force which finally led to the material overload i fatigue failure.Postoperative activities of the patient and a complex fracture situation may have played a certain role, too.A failure resulting from either a material defect or the manufacturing process can be excluded.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.

Manufacturer Narrative

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

Additional information was received on (b)(6) 2016.The patient further reported that the hand of the affected arm was supported by a fixation splint at all times and no strong forces were applied to the affected arm.

Manufacturer Narrative

Product investigation summary (additional details): based on the topography of the fracture surface, it is likely that the implant was subjected to moderate dynamic bending loads.Constant load cycles likely led to the fatigue of the material, then to a first crack, and finally to the overload fatigue that fractured the plate.The implant could not resist the applied forces, which finally led to the material failure.Postoperative activities of the patient and a complex fracture situation may have played a certain role, too.A failure resulting from either a material defect or the manufacturing process can be excluded.No product fault could be detected.All of the evaluation codes populated in the previous supplemental medwatch submission are still applicable.No new codes required.Correction: the event description on the initial medwatch incorrectly identified the date of discharge as (b)(6) 2015.The correct date was (b)(6) 2014.Device 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

Correction: the event description on the initial medwatch incorrectly identified the date of discharge as (b)(6) 2015.The correct date was (b)(6) 2014.

• Brand Name: 3.5MM TI LCP® METAPHYSEAL PLATE 14 HOLES
• Type of Device: APPLIANCES,FIXATION,NAIL/BLD/PL COMBO,MULTI COMP, METAL COM
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5286277
• MDR Text Key: 33247515
• Report Number: 3009450884-2015-10088
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK033805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 423.414
• Device Lot Number: 8915386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR