MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM - STERILE; SCREW, FIXATION, BONE

Catalog Number 02.211.014S

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2019

Event Type  malfunction  

Manufacturer Narrative

Initial alert date/ devices deemed reportable at the conclusion of the investigation on (b)(6) 2019 investigation summary: investigation flow: damage.Visual inspection: the va-lock scr 2.7 head 2,4 self-tap l14 ss (p/n: 02.211.014s, lot #: unk) was returned and received at us cq.Upon visual inspection,the locking threads were found to be stripped.In each instance the condition is consistent with difficulty locking the screws to the plate.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/specification review mre: a manufacturing record review was not performed since there was no lot number on the received device/provided by the customer.Complaint confirmed? yes, the device received is stripped.Hence confirming the allegation.Investigation conclusion the complaint condition is confirmed for the va-lock scr 2.7 head 2,4 self-tap l14 ss (p/n: 02.211.014s, lot #: unk).There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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)(6) as follows: it was reported that during the reduction and osteosynthesis with plate of the lateral malleolus surgery on (b)(6) 2019 to treat bi-malleolus fracture, the locking of the distal screw was defective.Consequently, the other screws became damaged.The surgeon used another 4 holes plate and screws.There was fifteen (15) minutes surgical delay.There was no clinical consequence but an increase of the infection risk linked to the increase of the operating time.Patient outcome is reported as back home, scheduled for follow up visit.This is report 6 of 8 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM - STERILE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9146113
• MDR Text Key: 169559116
• Report Number: 8030965-2019-68919
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819425132
• UDI-Public: (01)07611819425132
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.211.014S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1