MAUDE Adverse Event Report: SYNTHES SELZACH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 30MM; PLATE, FIXATION, BONE

Catalog Number 04.211.030S

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

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

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: patient identifier and weight are unknown.Additional product codes for this report include hwc.(b)(4).Device broke intra-operatively and 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.Device history record review: manufacturing location: (b)(4) - manufacturing date: november 20, 2015 - expiry date: november 1, 2025.The complaint was assessed as not related to sterilization.As such, the dhr records for the non-sterile counterpart were reviewed with results as follows: article 04.211.030 / lot 9804361; manufacturing location: (b)(4) - manufacturing date: may 13, 2015.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.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 surgery to treat a distal humerus extra-capsular fracture was performed on (b)(6) 2016.Due to the type of advanced fracture, the procedure took more than four (4) hours to achieve reduction of the spiral, cuneiform bone pieces distal to the humeral diaphyseal area.In fact, three (3) surgeons attempted to tract with maximum force before deciding to conduct a reduction procedure.A humeral plate was affixed with three (3) 2.7mm screws on the distal hole and three (3) 2.7mm screws on the proximal hole.At that point, the surgeon attempted to rotate the plate to the lateral part.At that moment, the screw heads of the three (3) distal screws broke away from the shafts.All of the screw fragments were retrieved with the use of pliers.The procedure was completed with a twenty (20) minute delay.Following the procedure, the surgeon stated that force was not applied when attempting to rotate the plate.However, the surgeon indicated that the rotating motion in general may have created an excess load that ultimately broke the screws.Concomitant device(s) reported: humeral plate (part/lot: unknown / quantity: 1).This report is 3 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

There was no patient harm.The surgery was successfully completed.

Manufacturer Narrative

A manufacturing investigation & invest.Summary was conducted/performed.The report indicates that: three screws with article number 04.211.018s / 04.211.022s and 04.211.030s were returned and sent for investigation.Here the feedback from the manufacturing plant: art: 04.211.030s with lot: 9734726 shaft thread -near the break point the screw thread could not be checked due to damage.On the tip end of the screw away from the break point the thread profile, thread major diameter and thread minor diameter are within specification.Head profile/thread ¿ could not be checked due to damage neck diameter ¿ could not be checked due to damage per the complaint description ¿three distal screws were broken at the screw head and the shaft part.¿ the available data supports the complainant¿s description therefore complaint is confirmed.However, since all the relevant features could not be evaluated due to screw damage 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 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 30MM
• 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: 5896442
• MDR Text Key: 52764544
• Report Number: 3000270450-2016-10214
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.030S
• Device Lot Number: 9734726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 08/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/15/2016; 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR