MAUDE Adverse Event Report: SYNTHES GMBH DHS/DCS LAG SCREW 12.7MM THREAD/110MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 280.100S

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

A product investigation was conducted.Visual inspection: dhs/dcs-scr ø12.5 l110 sst (p/n: 280.100s, lot #: 93p6089) was returned and received at us cq.Upon visual inspection, the proximal edge of the shaft was slightly deformed.No other issues were observed with the returned device.Dimensional inspection: measured dimensions: diameter of the shaft: conforming.Document/specification review:(current and manufactured): relevant drawing was reviewed.No design issues or discrepancies were identified.Investigation conclusion: the complaint could be confirmed for the returned device.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied on the device.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.A device history record (dhr) review was conducted: part: 280.100s, lot: 93p6089, manufacturing site: (b)(4), release to warehouse date: 19.Apr 2021.A manufacturing record evaluation was performed for the finished device 280.100s lot number 93p6089, and no non-conformance's were identified.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 a procedure on (b)(6) 2021 dynamic hip screw (dhs) lag screw appeared damaged/defective while registrar was trying to place the dhs plate over the screw.The lag screw was replaced with a new one.There was a five (5) minutes delay to insert a new screw.There was no patient consequence reported.During manufacturer's investigation of the returned device it was identified that he proximal edge of the shaft was slightly deformed.This device condition was re-evaluated and determined to be reportable.This report is for one (1) dhs/dcs lag screw 12.7mm thread/110mm-sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DHS/DCS LAG SCREW 12.7MM THREAD/110MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL (CH); dornacherstrasse 20; balsthal 4710 ; SZ 4710
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12533828
• MDR Text Key: 273374558
• Report Number: 8030965-2021-08066
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819055292
• UDI-Public: (01)07611819055292
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.100S
• Device Lot Number: 93P6089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: DHS/DCS