MAUDE Adverse Event Report: SYNTHES USA 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 13MM; SCREW, FIXATION, BONE

Catalog Number 201.763

Device Problem Break (1069)

Patient Problems Pain (1994); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Date of postoperative pain and non-union is unknown.The original implant procedure occurred on an unknown date approximately one and one-half (1 ½) years ago.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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.

Event Description

It was reported that a patient had a distal radius revision surgery performed on (b)(6) 2015 after it was noted on x-rays that the patient had a broken plate and nonunion.The plate broke at the distal-combi at an occupied screw hole.The broken plate and eleven (11) intact screws were removed.The patient had two (2) lag screws in the radial shaft of an ulnar plate that had no device allegations and were, therefore, left implanted.The original surgery was performed approximately a year and a half ago.X-rays taken in (b)(6) 2014 were normal.Recently, however, the patient started working out and began experiencing pain.Subsequent x-rays confirmed the nonunion and plate breakage.The revision surgery was successfully completed with no surgical delay.This report is 4 of 12 for (b)(4).

Manufacturer Narrative

A product investigation summary ¿ the returned parts are used with procedures involving the 2.4mm variable angle lcp distal radius system for fixation of fractures of the distal radius.The returned narrow 2.4mm variable angle lcp two-column volar distal radius plate (02.111.550, 3315940) was received broken into two pieces at the distal combi hole and has scratches on its surface; indicative of an explanation.The returned screws (201.760 (2), 201.763 (3), 02.210.110 (1), 02.210.114 (1), 02.210.116 (3), and 02.210.118 (1)) were received intact but were included as adverse event complaint parts with no reported product problem.The returned narrow 2.4mm variable angle lcp two-column volar distal radius plate (02.111.550, 3315940) was manufactured on 17dec09 and the device drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The complaint description indicated that the patient¿s post-surgical x-rays were normal.X-rays were not made available as part of the complaint so analysis of post-surgical or post-plate breakage x-rays was not possible.The complaint description stated that the patient began working out, after which she began to experience pain.Based on inspection of the returned parts and the available information it is not possible to determine a definitive root cause.It is possible that the patient was non-compliant, which could have prevented the patient¿s bone from healing properly and contributed to the non-union and ultimately plate breakage.Additionally, the plate which was implanted was a ¿narrow¿ plate which is a possible indication that the patient had unusually small bones, which could be more susceptible to breakage.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: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 13MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5086749
• MDR Text Key: 26160118
• Report Number: 2520274-2015-15967
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 201.763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR