MAUDE Adverse Event Report: SYNTHES GRENCHEN; PLATE, FIXATION, BONE

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

Patient id/initials and weight are unknown.This report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.It is unknown which device broke it may have been any one of the following: part 04.224.223s (lcp dhs-pl 135° 3ho l76 standbarrel tan), lot 9366223; product code: hrs, common name: plate, fixation, bone; (b)(4); 510k: device is not distributed in the united states, but is similar to device marketed in the usa.Part 480.850s (ti dhs/dcs lag screw 12.7mm thread/85mm), lot 9482004; product code: jdo, common name: appliance, fixation device, proximal femur; (b)(4); 510k: k953607.Part 414.836s (4.5mm ti cortex screw self-tapping 36mm), lot 9370673, 9499858, or 9311905; product code: hwc, common name: screw, fixation, bone; (b)(4); 510k: k112583.Part 408.280vs (cannscr ø6.5 l80/20 tav), lot 9804298; product code: hwc, common name: screw, fixation, bone; (b)(4); 510k: device is not distributed in the united states, but is similar to device marketed in the usa.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).A review of the device history records or all the potential part/lot numbers was completed: articles were sterilized by supplier (b)(4).No deviations or non-conformance reports were marked in the device history records.Part: 04.224.223s, lot 9366223 (non-sterile part 04.224.223, lot 9232790): manufacturing date: february 13, 2015, expiry date: february 01, 2025.Part 480.850s, lot 9482004 (non-sterile part 480.850, lot 9205697): manufacturing location: (b)(4).Manufacturing date: may 13, 2015, expiry date: may 01, 2025.Part 414.836s, lot 9370673 (non-sterile part 414.836, lot 9312583): manufacturing date: february 17, 2015.Expiry date: february 01, 2025.Part 414.836s, lot 9499858 (non-sterile part 414.836, lot 9478369): manufacturing date: may 28, 2015.Expiry date: may 01, 2025.Part 414.836s, lot 9311905 (non-sterile part 414.836, lot 9284400): manufacturing date: january 09, 2015.Expiry date: december 01, 2024.Part 408.280vs, lot 9804298: manufacturing date: february 04, 2016.Expiry date: january 01, 2026.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: during the surgery for intertrochanteric femoral fracture, on (b)(6) 2016 the surgeon found metal debris under image intensifier control after performing the surgery.Therefore, the surgeon directly confirmed the debris in the patient.Although the surgeon thus attempted to remove the metal debris, he could not remove all of the debris from the patient's body.The surgeon tried to find where the debris came from.However, he could not specify what product was broken to generate the metal debris.The surgery was extended for sixty (60) minutes due to the event.Procedure was successfully completed and no other medical intervention was required.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A sample of the reported metal debris was returned for evaluation; however, as previously reported, the device which may have generated the debris is unknown and was not returned.The metal debris sample is undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.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 metal debris was sent back for material analysis for investigation.The three small particles were analyzed for the chemical composition and also underwent a macroscopic assessment.The debris was analyzed in the scanning electron microscope (sem) by applying energy dispersive x-ray spectroscopy (eds) to receive the chemical composition.The macroscopic assessment revealed that they have a metallic appearance and swarf like shapes.The eds measurements showed that they consist mainly of iron (fe) with significant amounts of nickel (ni), chrome (cr) and molybdenum (mo).The high amounts of carbon (c) and oxygen (o) as well as the several measured traces of other elements are negligible because the particles were obviously still contaminated with organic material such as bone and/or human tissue as well as maybe cleaning agents.It is high probability that these are swarf from a high alloyed steel.The review of the device history record to the reported articles showed no deviation and conformity to specifications.The root cause could not be determined as it is not clear which devices were used during this surgery and it is unknown which device provided the fragments.It is unknown if plate or screws or other implants or instruments broke.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5989936
• MDR Text Key: 56010779
• Report Number: 3009450884-2016-10102
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 09/30/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/08/2016; 11/14/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR