MAUDE Adverse Event Report: SYNTHES SELZACH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM; PLATE, FIXATION, BONE

Catalog Number 04.211.020S

Device Problems Failure To Adhere Or Bond (1031); Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Due to intra-operative issues, the device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Sterile part 04.211.020s, lot 9825707: manufacturing location: (b)(4).Manufacturing date: february 15, 2016.Expiry date: february 01, 2026.Article was sterilized by supplier (b)(4).Non-sterile part 04.211.020, lot 9983934: manufacturing location: (b)(4).Manufacturing date: january 21, 2016.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the surgeon had difficulty while trying to insert a screw.The surgeon felt like the screw was not going to the direction where he drilled so he changed the direction several times and tried to insert the screw; however, he couldn't do the final lock.There were two pieces of fragment tips produced.The surgeon thinks that the thread of the screw hole of the plate might be scraped due to force of changing the direction of screw insertion; it is unknown if the fragments were from the screw, the plate or both.The multiple changes of directions might also have cause the screw not to be locked.The surgeon believes the set up of the funnel of the drill was done properly and he drilled by variable angle.There was a ten (10) minute surgical delay.No adverse consequence was reported; the fragment tips did not remain in patient's body.There was no patient harm and the surgery was completed successfully.This is report 1 of 2 for com-(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.

Manufacturer Narrative

Product investigation summary: part: 04.211.020s / lot: 9825707 was received for evaluation.A review of the device history record confirms that this lot was manufactured according to the specifications and was released after successful final inspection.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.A microscopic investigation clearly shows that the locking thread is badly damaged.The tread is plastically deformed, which does not allow locking of the screw head in the plate.Also, the thread at the screw shaft is deformed.This led to the conclusion that the screw was not properly aligned during insertion.The thread came into hard contact with the plate, which finally caused the reported damage to the threads.A handling error is, therefore, the likely cause.As such, a manufacturing issue can be excluded.No indication for material, manufacturing, or design related issue was found.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.

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 20MM
• 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: 5889863
• MDR Text Key: 52552659
• Report Number: 3000270450-2016-10208
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103243
• 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: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.020S
• Device Lot Number: 9825707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1