MAUDE Adverse Event Report: SYNTHES BALSTHAL DHS®/DCS® LAG SCREW 12.7MM THREAD/100MM; APPLIANCE,FIXATION,NAIL

Catalog Number 280.000

Device Problems Fitting Problem (2183); Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2017

Event Type  malfunction  

Manufacturer Narrative

Pt identifier: (b)(6).Pt weight: patient information is unknown.Implant and explant date is not applicable since it was discovered before used on patient.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter telephone number: (b)(6).Manufacturing location: (b)(4).Manufacturing date: 16 december 2011.No nonconformances were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.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 (b)(4) reports an event in (b)(6) as follows: it was reported that dhs screw could not pass through the dhs plate during testing before inserting into the patient.They had to open another similar set for like product.Prolongation of the surgery: 2 minutes / procedure was completed successfully.Concomitant part: unknown dhs plate, (part# unknown / lot# unknown / quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: the device has been received and the product evaluation is in progress.No conclusion can be drawn.(b)(4).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.A product investigation was performed for the subject device (brand name dhs®/dcs® lag screw 12.7mm thread/100mm, part number 280.000, lot number 7702656).Microscopic examination of the subject device shows post manufacturing damage; the positioning groove of the dhs/dcs® screw was expanded and damaged.The outside diameter at the area of the positioning groove therefore is enlarged and is the reason why the dhs/dcs® screw does not pass the bore of the lcp dhs® plate anymore.The side walls of the positioning groove show dents and marks; the dimensions therefore cannot be verified to post manufacturing specifications.The outside diameters were measured with caliper ref.3-01-19789 at the area straight before the damage referring to the valid technical drawing and met fully to the specifications.The specified size for the shaft diameter is 7.9 +0/-0.05 mm and the actual size is 7.88 mm; the specified size of the diameter with milled surfaces is 7.15+0/-0.08 mm and the actual size is 7.12 mm.The dhr review revealed that the dhs/dcs® screw was manufactured according to the specifications.No manufacturing related issues that would have contributed to this complaint were found.Please note, in order to prevent such occurrence and to ensure a correct load transfer it is crucial to have an appropriate connection between the dhs-screw and the connecting screw 338.310, which is guided through the appropriate dhs/dcs wrench.The associated surgical technique guide contains the warning note: to avoid damaging the instruments and the implant, tighten the connecting screw securely.The complaint condition is confirmed; however, based on the investigations findings it was concluded that the cause of failure is not due to any manufacturing non-conformances and was caused during post manufacturing mechanical overloading.(b)(4).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 12.7MM THREAD/100MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer (Section G): SYNTHES BALSTHAL; dornacherstrasse 20; balsthal CH471 0; SZ CH4710
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6374957
• MDR Text Key: 68970689
• Report Number: 3009450863-2017-10005
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 07611819012547
• UDI-Public: (01)07611819012547(10)7702656
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2017

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: 280.000
• Device Lot Number: 7702656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/29/2017; 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2011
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 1 QTY OF UNKNOWN DHS PLATE
• Patient Age: 82 YR