MAUDE Adverse Event Report: SYNTHES RARON 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT

Catalog Number 441.903

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); No Known Impact Or Consequence To Patient (2692)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that after the initial implantation on (b)(6) 2014, the patient was diagnosed with a fractured left humerus; the patient had not healed; there was a four part fracture with subsequent humeral head necrosis and iatrogenic shaft fracture of the left humerus.The patient had a re-operation on (b)(6) 2015 to remove the philos implant and implant a 12-hole locking compression plate (lcp) and epoca shoulder hemiprosthesis.During the re-operation procedure, the whole plate could be removed intact.At this time, the shaft was still intact.The humeral shaft fracture must have occurred unnoticed.After the fracture had been noticed, this was inspected, and the decision was made to splint this with an lcp plate; a 7-hole lcp plate was used initially, with placement of screws in the philos plate holes proximal to the fracture.After a 10-minute interval, by which time the cement had hardened, a longer lcp plate was inserted, switching from the 7-hole to a 12-hole plate, which was swiveled in position somewhat distally; the access was meanwhile extended distally.

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows:it was reported that a humeral head necrosis implant removal, shaft fracture, re-osteosynth, hemiprosthesis (cemented).The involved plate has the part # 441.903 / lot #8706648.This complaint involves 1 part.This report is 1 of 1 for (b)(4).

Event Description

Update (b)(6) 2015: the x-ray review confirms that were 9 screws inserted in total in the plate ¿ 6 in the head and 3 down the shaft / it is also confirmed that here is humeral head necrosis and a shoulder hemiarthroplasty was performed.

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: no non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Year of birth reported as 1931, month and day unknown.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

Updated information internal review was performed.The investigation of the complaint articles indicates that: no investigation possible as there was no material available, there is no indication of a product fault, for information only.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: 3.5MM TI LCP® PROXIMAL HUMERUS PLATE-STANDARD 5H SHAFT/114MM
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT
• Manufacturer (Section D): SYNTHES RARON; kanalstrasse west 30; raron CH39 42; SZ CH3942
• Manufacturer (Section G): SYNTHES RARON; kanalstrasse west 30; raron CH39 42; SZ CH3942
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4693146
• MDR Text Key: 5650984
• Report Number: 3006126083-2015-10027
• Device Sequence Number: 1
• Product Code: KTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK011815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 441.903
• Device Lot Number: 8706648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR