MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH DHS®/DCS® LAG SCREW 14.0MM THREAD/80MM; APPLIANCE, FIXATION, NAIL

Catalog Number 280.480

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Code Available (3191)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

Event: unknown date in 2017.Additional product code: jdo.Due to intra-operative issues, the device was not implanted/explanted.It is unknown if the complainant part is available to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during surgery the dynamic hip system (dhs) 14mm diameter screw did not fit with the dhs plate.The surgeon had to use a 12.5mm diameter screw instead.Concomitant reported part: lcp dhs® plate 135° (part 02.224.222s, lot unknown, quantity 1).This complaint involves 1 part.

Manufacturer Narrative

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

The surgery took place on (b)(6) 2017.It was noted the procedure was successfully completed.

Manufacturer Narrative

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.

Manufacturer Narrative

A review of the device history records has been requested.The device has been received, the investigation is in progress, 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.

Manufacturer Narrative

Part: 280.480; lot: h230729; part manufacturing date: december 21, 2016; manufacturing site: (b)(4); part expiration date: n/a; nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h230729 was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot 6956060 met all specifications with no issues documented that would contribute to this complaint condition.Investigation selection investigation site: (b)(4); selected flow: 2.Device interaction/ functional visual inspection: the investigation of the dynamic hip screw/dynamic condylar screw (dhs/dcs) has shown that the positioning groove on top of the screw is damaged and widened up.Functional test: the relevant features are damaged in a manner which prevents accurate functional check.Dimensional inspection: checked dimensions with caliper per drawing.Outer shaft diameter below the groove: specification 7.9mm 0/-0.05 / measured: 7.86mm = pass.Distance flat surfaces below the groove.Specification 7.15mm 0/-0.05 / measured 7.14 = pass.Distance flat surfaces at the groove.Specification 7.15mm 0/-0.05 / measured 7.22 = damaged post-manufacturing.Drawing/specification review: the manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Summary: the investigation of the dhs/dcs screw has shown that the positioning groove of the screw is damaged and widened up; this damage makes an insertion of the plate impossible and the complaint is confirmed.The relevant dimensions below the damaged groove were checked and no deviation was detected.No product related issue could be detected.The damage clearly occurred post-manufacturing.We assume that the connection between the wrench and the screw was not aligned as intended and therefore this occurrence in combination with a mechanical overload situation did lead to the deformation of the groove.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.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.

• Brand Name: DHS®/DCS® LAG SCREW 14.0MM THREAD/80MM
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7126000
• MDR Text Key: 95171605
• Report Number: 8030965-2017-50787
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819868892
• UDI-Public: (01)07611819868892(17)EXPIRATIONUNKNOWN(10)LOTUNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K791619
• 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,Followup,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.480
• Device Lot Number: H230729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 42