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 Break (1069); Material Separation (1562)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

Additional classification code: hwc.(b)(4).(b)(6).Device history record (dhr) review is for sterilization procedure only: manufacturing location: (b)(4).Supplier: (b)(4).Manufacturing date: 19.Oct.2016 expiry date: 01.Oct.2026.No nonconformances 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.Non-sterile 04.211.018 / h193440 was manufactured in us.For non-sterilization, the dhr is as follows: manufacturing location: (b)(4).Manufacturing date: 27-sep-2016.Part #: 04.211.018, lot#: h193440 (non-sterile) - 2.7mm ti va lckng scr slf-tpng with t8 stardriver recess 18mm.Qty: 227.Components: 04.211.018.999, 2.8mm ti screw blank 18mm, lot h191463.No nonconformances 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.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the reported devices were used in surgery for distal humeral fracture on (b)(6) 2017.A va (variable angle) locking screw head was broken when the surgeon tightened the screw.He decided leaving the screw shaft in the patient and closed a surgical incision.When he inserted the screw, he drilled with angular adjustment guide but some kind of metal piece came out.The surgeon commented because he inserted the screw and a cortex screw 3.5mm in the same bone fragment, screw head bears a burden and it was broken.The surgeon couldn't extract the broken part and left it inside the patient.There is no information available about surgical outcome.Patient status is good, no other medical intervention was required.There was no surgical prolongation reported.Concomitant medical products: 1x unk angular adjustment guide; 1x unk 3.5mm cortex screw (204.Xxx) 1x 04.117.309s / 9306099 (va-lcp dhp 2.7/3.5 dorso-lat le x-long 9).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Health professional was added as additional report source.A manufacturing investigation was performed for the subject device (2.7mm ti va lckng scr slf-tpng with t8 stardrive recess 18mm (sterile), part number 04.211.018s, lot number l168650).The subject device was returned to the manufacturer with the complaint condition stating the locking screw head was broken when the surgeon tightened the screw.He decided leaving the screw shaft in the patient and closed a surgical incision.When he inserted the screw, he drilled with angular adjustment guide but some kind of metal piece came out.The surgeon commented because he inserted the screw and a cortex screw 3.5mm in the same bone fragment, screw head bears a burden and it was broken.The surgeon couldn't extract the broken part and left it inside the patient.The screw head of article 04.211.018s with lot l168650 was returned to the synthes manufacturing plant for investigation.There was wear on the thread heads and the anodize color was stripped off.A dimensional analysis could not be done since features were unobtainable or damaged.The available data supports the complainant¿s description of the complaint condition that ¿a va (variable angle) locking screw head was broken when the surgeon tightened the screw.¿ therefore this complaint is confirmed.However since all the relevant features could not be evaluated it is unknown if the cause of the complaint condition is a result of manufacturing process.In reference on to the provided dhr-review from manufacturing plant it should be noted that the final inspection of mill shaft threads, turn/thread head, flute meet inspection acceptance criteria.No nonconformance reports (ncrs) were generated during production.No issues during the manufacture of the product that would contribute to this complaint condition were found.Device history records for both the sterile finished product (manufacturer (b)(4)) and the non-sterile part (04.211.018, lot h193440, manufacturer (b)(4)) were reviewed.The complaint condition was confirmed; however, an exact root cause for this screw breakage could not be obtained during the manufacturing investigation.No indication for product related issue was found.Due to the intra-operative events, the device was not successfully implanted.As such, implant/explant dates are not applicable.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.The date received by manufacturer reported in supplemental medwatch report (b)(4), apr 11, 2016, was reported in error and should have been apr 11, 2017.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 CO CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CO CH254 5; SZ CH2545
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6398724
• MDR Text Key: 69857125
• Report Number: 1719045-2017-10217
• 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: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• 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: L168650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ONE QTY UNKNOWN 3.5 MM CORTEX SCREW; ONE QTY UNKNOWN ANGULAR ADJUSTMENT GUIDE; PART # 04.117.309S, LOT# 9306099, QTY 1
• Patient Age: 20 YR