MAUDE Adverse Event Report: SYNTHES SELZACH DHS®/DCS® LAG SCREW 14.0MM THREAD/100MM-STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 280.504S

Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a dynamic hip system (dhs) plate does not fit over the screw.The screw was noted as being too big.The surgeon switched out the screws and continued the procedure.A delay of 15 minutes was noted.No reported patient harm.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Patient identifying information is not available for reporting.Complainant part was not implanted/explanted.Complainant part was received for manufacturer review/investigation on january 16, 2015 subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.Device history review: manufacturing location: (b)(4) - manufacturing date: july 29, 2014 - expiry date: july 1, 2024.This complaint is assessed as not related to sterilization.Thus, the documents for the corresponding non sterile part 280.504 lot 7522586 were reviewed with the following result: a non-conformance report (ncr) with the number (b)(4) was created during the manufacturing process.Length of raw material exceeded that which was in the specifications.The outcome of the ncr was: "the actual length of the bar will not affect the part quality or the bar loader operation." device 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 manufacturing evaluation was conducted.The report indicates that the dhs/dcs® screw were checked and found to be in compliance with the technical drawings and ao/asif specification.No product fault could be found.Our investigations have shown that the positioning groove of the screw has been widened up due to inadequate handling.The groove is expanded and damaged and therefore the plate does not pass the slotted end of the dhs/dcs screw.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

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/100MM-STERILE
• Type of Device: APPLIANCE, FIXATION, NAIL
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CO 80132 CH2; SZ 80132 CH25
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CO 80132 CH2; SZ 80132 CH25
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4433903
• MDR Text Key: 17628814
• Report Number: 1719045-2015-10051
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK791619
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 280.504S
• Device Lot Number: 9080383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 01/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2015; 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1