MAUDE Adverse Event Report: SYNTHES SELZACH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM--STERILE; PLATE, FIXATION, BONE

Catalog Number 04.211.018S

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Fracture, Arm (2351); Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information is not available for reporting.Additional device product code is hwc.Other number¿udi: (b)(4).(b)(6).Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, no implant/explant dates are applicable.The complaint device is expected to be returned to the synthes manufacturer for evaluation but has not yet been received.A device history record review was performed for the complaint 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 complaint device.The finished sterile lot was manufactured by synthes (b)(4).The lot was sterilized by supplier, (b)(4).Manufacturing date: jan 18, 2016.Expiry date: jan 1, 2026.The original non-sterile lot was manufactured by synthes monument as part number 04.211.018, lot number 9969987 on dec 28, 2015.A review of the device history records for the non-sterile lot showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

Synthes europe reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2016 to address pseudarthrosis following an olecranon osteotomy, three screws broke and the patient's elbow was fractured when the surgeon removed wire and applied the variable angle olecranon plate.The surgeon had inserted two locking screws (2.7mm) into the proximal holes and two cortex screws (3.5mm) into the distal holes of the plate.The surgeon then flexed and extended the elbow joint with the plate and screws several times.A dull sound came from the operated site of the elbow joint.The surgeon detected the elbow fracture first.The surgeon then detected the breakage of the reported screws (22mm and 18mm).Both screws were broken between the head and the shaft.Although the 22mm screw was successfully removed, the 18mm screw shaft was not able to be removed.Only the head of the 18mm screw was able to be easily removed.The surgeon decided to leave the shaft of the 18mm screw in the patient's bone.The surgeon tried to insert the reported the 60mm screw at the desired angle after the breakage of the screws of the previously mentioned screws.This screw also broke at the screw head/shaft upon the final tightening when insertion was nearly complete.The surgeon stated that there was some difficulty [resistance] felt during the insertion right before the breakage.The surgeon tried to remove the broken 60mm screw; however, the only the head of the screw could be easily retrieved.The surgeon opted to leave the shaft of the 60mm screw in the patient's bone.The surgery was delayed by five (5) minutes due to the reported events.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

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 Description

Concomitant medical products: variable angle olecranon plate (part and lot unknown, quantity 1); screwdriver or screwdriver shaft (part and lot unknown, quantity 1).

Manufacturer Narrative

A manufacturing investigation action was conducted/performed.The report indicates that the: per the complaint description ¿screws were broken at the place between the head and the shaft.¿ the surgeon attempted to remove the broken screw but only the head could be removed.The shaft of the screw remains in the patient.The available data supports the complainant¿s description therefore complaint is confirmed.However, since all the relevant features could not be evaluated due to unavailability of the entire screw it is unknown if the cause of the complaint condition is a result of the manufacturing process.Additionally the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this 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: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM--STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5865795
• MDR Text Key: 51767947
• Report Number: 3000270450-2016-10202
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.018S
• Device Lot Number: 9793917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR