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

Catalog Number 04.211.018S

Device Problems Difficult to Insert (1316); Dull, Blunt (2407)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: additional product codes for this report include hwc.(b)(4).Due to the intra-operative issues with the screw(s), the device was not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.A review of the device history records has been requested and is currently pending completion.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

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure on (b)(6) 2016 in order to treat at humerus fracture (distal end).During plate insertion, the surgeon used a variable angle (va) drill sleeve to drill at a fixed angle.Thereafter, a va locking screw was inserted with a torque driver, but it would not lock into the plate.The surgeon noted that the screw was idling inside the plate hole.Further, it was noted that, without the posterolateral plate support, the issue occurred within four (4) of the five (5) distal plate holes as well.The threads on all four (4) screws had reportedly worn out.No additional information is available as to how the procedure was completed.However, it was noted that a sixty (60) minute delay was recorded.Concomitant device(s) reported: plate (part/lot: unknown / quantity: 1).This report is 2 of 4 for (b)(4).

Manufacturer Narrative

Sterile part 04.211.018s, lot 9921876: manufacturing location: (b)(4)/us.Manufacturing date: april 22, 2016.Expiry date: april 01, 2026.Article was sterilized by supplier (b)(4) with lot number 9921876.Non-sterile part 04.211.018, lot h044615: manufacturing location: (b)(4).Manufacturing date: february 25, 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 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

Device was used for treatment, not diagnosis a product development investigation was performed for the subject device.Two (2) va lockscr ø2.7 head 2.4 self-tap l20 ta (part 04.211.018s, lot 9921876, mfg.Date; april 22, 2016) and two (2) va lockscr ø2.7 head 2.4 self-tap l20 ta (part 04.211.020s, lots 9877835 / 9944345, mfg.Date; march 21, 2016 / may 12, 2016) were returned.The visual entrance inspection detected strong worn head threads.The visual inspection/examination with microscope showed that the screw head thread are badly worn and unfortunately based on the strong damage no measurements could be taken.The shaft section is partially worn.The review of the device history record was conducted for every screw and showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No ncrs were generated during production.Dcrm-review: was reviewed and found to adequately address the harm of this complaint condition.The exact root cause could not be defined.Based on the dhr-review and visual inspection no manufacturing related failure could be found.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
• 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: 5950418
• MDR Text Key: 54701063
• Report Number: 3000270450-2016-10221
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.018S
• Device Lot Number: 9921876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN PLATE
• Patient Age: 50 YR
• Patient Weight: 84