MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM; SCREW, FIXATION, BONE

Catalog Number 04.211.022S

Device Problem Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

Additional pro-code: hrs.Complainant part returned for manufacturer review/investigation.Zip code: (b)(6).(b)(4).The reported event required medical/surgical intervention to preclude permanent damage to a body structure and the screws and plate would not lock.The surgeon inserted screws without locking.Not locking the devices results in less than optimal fixation.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 reports an event in (b)() as follows: it was reported that on (b)(6) 2019, the patient underwent the surgery with the va distal humerus plate and the 3 locking screws in question.After the surgeon drilled the va locking hole with a drill sleeve 2.7 at an angle, he inserted the locking screw, but the locking mechanism between the screw and the plate didn¿t work properly.When the surgeon removed the screw, he found that the screw head was shaved off and a thread fragment was generated.The surgeon tried to insert another locking screw, but the screw head was shaved off, too.The locking mechanism of the plate didn¿t work completely because the surgeon tried to insert a few times.The surgeon inserted the screw manually into the hole without locking it, and he finished the surgery.No further information is available.Concomitant device reported: unknown drill sleeve (part# unknown, lot# unknown, quantity# 1).This complaint involves four (4) devices.This report is 2 of 4 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: we received three (3) screws back for investigation.All screws were found deformed and damaged at the threaded head as well as at the threaded shaft.The anodized layer is partially disappeared at all damaged areas which does confirm a post manufacturing damage.Moreover, one (1) of three (3) screws was found deformed at the screw-recess.The relevant mating part (plate) was not returned.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: a dimensional test is not appropriate to all received screws, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The correct material was used according to iso 5832-11.Conclusion: the complaint condition is confirmed due to the bad condition of the screws.This damage is clearly caused post manufacturing considering the evidence that anodized layer is partially disappeared.Based on the findings above a manufacturing related issue can be excluded.It was determined that the devices became deformed due to post manufacturing damage which was likely caused by handling error such as excessive force application and/ or alignment issues during insertion procedure.During the investigation, manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Pictures are attached at pi-(b)(6) device history sterile part: part: 04.211.022s.Lot: 2l17039.Manufacturing site: selzach.Supplier: früh verpackungstechnik ag.Release to warehouse date: 07.11.2018.Expiry date: 01.Oct.2028.Manufacturing document record review for sterility wasn't done, as this is not needed for the reported issue function/device interaction (between screw and plate).Unsterile part: part: 04.211.022.Synthes lot: h750589.Supplier lot # na.Release to warehouse date: 05 oct 2018.Manufactured by synthes monument.No ncr's were generated during production.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

Update: no fragments remained in the patient.

• Brand Name: 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 22MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9101185
• MDR Text Key: 159487063
• Report Number: 8030965-2019-68538
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819444171
• UDI-Public: (01)07611819444171
• Combination Product (y/n): N
• PMA/PMN Number: K100776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.211.022S
• Device Lot Number: 2L17039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 10/10/2019
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - GUIDES/SLEEVES/AIMING: SLEEVE
• Patient Outcome(s): Required Intervention