MAUDE Adverse Event Report: SYNTHES SELZACH 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 24MM F/IM NAILS-STER; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.005.414S

Device Problem Fitting Problem (2183)

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

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.(b)(6).The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: may 6, 2016.Expiration date: apr 1, 2026.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.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 (b)(6) as follows: it was reported that during surgery to treat a proximal humeral fracture on (b)(6) 2017 with a 8mm multi-lock short nail and 4.0mm locking screw, the locking screw stuck in the driver and was not able to be detached.The surgeon opted not to insert screws into the hole.The surgery was delayed 10 minutes due to the reported event.Concomitant parts: multi lock short nail 8mm (part# unknown / lot# unknown / quantity 1).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a product development investigation was performed for the subject device (4.0mm ti locking screw w/t25 stardrive 24mm f/im nails-ster, part number 04.005.414s, lot number 9918433.The subject device was returned with the complaint condition stating: 04.005.414s / 9936713 locking screw visible inspection shows that the part is in complete faultless condition.No signs of damage could be identified.Part 03.019.020 / 8318595 screw driver.Visible inspection shows that the part is in faultless condition.Even there are some signs of multiple use visible at the torx tip, the instrument is still in faultless condition and its function is as intended.Carried out functional test of the two complained part could not reproduce the reported problem.The screw could be assembled and disassembled to the screw driver as intended without any problems and force.No product related issue could be identified.We are not able to identify the root cause for the reported problem.Both parts are in faultless condition.Corrected data: 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.Additional device product code is hwc.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 24MM F/IM NAILS-STER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6362496
• MDR Text Key: 68470487
• Report Number: 3000270450-2017-10060
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103002
• 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: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.005.414S
• Device Lot Number: 9918433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN, MULTI LOCK SHORT NAIL 8MM, QTY 1