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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES (USA); PLATE, FIXATION, BONE
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SYNTHES (USA); PLATE, FIXATION, BONE Back to Search Results
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Patient age or date of birth and weight not available for reporting.This report is for an unknown distal radius plate.Part and lot numbers are unknown; udi number is unknown.It is unknown if the two fragments were generated from the plate or from the instruments used during initial surgery: soft tissue bone reduction forceps with ball tips (part 03.111.750) or soft tissue attachment/j-shaped for bone reduction forceps (part 03.111.751) date of explant reported as mid (b)(6) 2017.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Hospital address and telephone not available for reporting.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: the reported devices were used in the surgery for distal radial fracture on (b)(6) 2017.The unknown distal radius plate was implanted during the procedure.Four (4) months after the primary surgery, the patient felt something wrong in the suturing site.Patient was returned to surgery sometime in mid (b)(6) 2017.When the surgeon opened the suturing site, two foreign matters (2 mm in size, like a black-colored metal) were found.The surgeon suspected two foreign matters might be parts of the forceps that were used in the primary surgery.No patient harm was reported.Patient status reported as okay.This report is for one (1) unknown distal radius plate.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
A product investigation was completed: small foreign black pieces were returned in a plastic container.A visual examination of the foreign pieces was completed.On the pictures taken by microscope there are abrasions visible black possible from plastic like soft tissue attachment, part 03.111.751 mentioned in connection with this complaint.Further there are some other gold colored particles which could be shaved off an implant and some other material it look like blue liquid.No pictures during surgery or x-rays were received.As an overall conclusion we could not determine where those foreign pieces were from.We can confirm this complaint as foreign pieces were returned like complained, but we cannot confirm that those foreign pieces are part of a synthes implant or instrument as there might be other non-synthes implants/instruments used during the procedure as well.The exact root cause of this complaint could not been replicated.We do conclude that no manufacturing related deviation has led to this complaint.No indication for product related issue was found.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
The investigation summary indicates that: as a root cause, we do point out that a drill bit has hit the soft tiss attach j-shap f/reduc forceps and black foreign small pieces were removed.User error must have been taken place.No indication for product related issue was found.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
Updated information provided, & addition of 25 concomitant devices reported.Concomitant parts: no investigation was provided on them as there can no connection to be drawn to the complained issue with small foreign black pieces.1 x 323.202/ 3724225 univ-drill-guide 2.4, 1 x 323.260/ 8092116 univ-drill-guide 2.7, 1 x 03-110.000/ 2706737 va-lcp drill sleeve 2.4 f/drill bit o1.6, 1 x 323.029/ 1984233 lcp drill sleeve 2.4 w/scal-30 f/drill b, 1 x 03.111.000/ 09-4567 quick drill sleeve 2.4 w/scal f/drill bi, 1 x 310.509/ l209813 drill bit o1.8 w/marking l110/85 2flute, 1 x 310.509/ l026428 drill bit o1.8 w/marking l110/85 2flute, 1 x 310.534/ 9728246 drill bit o2 w/marking l110/85 2flute, 1 x 310.534/ 9564096 drill bit o2 w/marking l110/85 2flute, 1 x 310.530/ 9292686 drill bit 02.4 l1oon5 2flute, 1 x 310.260/ 8265173 drill bit 02.1l1oon5 2flute, 1 x 324.084/ 2115371 cent-sleeve f/k-wire 01.25 sst, 1 x 314.468/ 9973119 hold-si f/scr o2.4 tb f/scrdriver shafts, 1 x 03.111.005/ 3725601 depth gauge f!scr 02-2.7 meas-range, 1 x 03.110.005/ 2708805 handle f/torque limiters 0.4/0.8/1.2nm, 1 x 311.430/ 2707911 handle w/quick-coupl l110, 1 x 399.071/ 5009647 reduc-forc w/point softlo l126, 1 x 399.074/ 5904217 reduc-forceps w/points wide softlo l127, 2 x 347-901/ 3632697 pliers flat-nosed pointed f/pi 1-2.4, 1 x 399.180/ 5909959 bonelever small short narrow tip wf6 16, 1 x 399.480/ 5910204 periost-elev slightly curv-blade straigh, 1 x 399-481/ t961615 periost-elev round edg w/3 curved blade, 1 x 323.029/ 2165825 lcp drill sleeve 2.4 w/scal-30 f/drill b, 1 x 03.111.000/ 13-5229 quick drill sleeve 2.4 w/scal f/drill bi, 1 x 03.111.750/ t102765 reduc-forc w/ball tips.Investigation summary: the returned article 03.111.751 / soft tiss attach j-shap f/reduc forceps we identified as root cause for the black foreign pieces as a hole caused by a drill bit was detected.Pictures are attached were the hole is marked with orange circle.Dhr-review: 03.111.751 / 513085, manufacturing location: (b)(4) / supplier: (b)(4), manufacturing date: 03.Aug.2016.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.We can confirm this complaint as foreign pieces were returned like complained.As root cause pointed out, a drill bit has hit the soft tiss attach j-shap f/reduc forceps and black foreign small pieces were removed.User error must have been taken place.The exact root cause of this complaint could not been replicated.We do conclude that no manufacturing related deviation has led to this complaint.No indication for product related issue was found.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
Concomitant parts: no investigation was provided on them as there can no connection to be drawn to the complained issue with small foreign black pieces.1 x 323.202/ 3724225 univ-drill-guide 2.4, 1 x 323.260/ 8092116 univ-drill-guide 2.7, 1 x 03-110.000/ 2706737 va-lcp drill sleeve 2.4 f/drill bit o1.6, 1 x 323.029/ 1984233 lcp drill sleeve 2.4 w/scal-30 f/drill b, 1 x 03.111.000/ 09-4567 quick drill sleeve 2.4 w/scal f/drill bi, 1 x 310.509/ l209813 drill bit o1.8 w/marking l110/85 2flute, 1 x 310.509/ l026428 drill bit o1.8 w/marking l110/85 2flute, 1 x 310.534/ 9728246 drill bit o2 w/marking l110/85 2flute, 1 x 310.534/ 9564096 drill bit o2 w/marking l110/85 2flute, 1 x 310.530/ 9292686 drill bit 02.4 l1oon5 2flute, 1 x 310.260/ 8265173 drill bit 02.1l1oon5 2flute, 1 x 324.084/ 2115371 cent-sleeve f/k-wire 01.25 sst, 1 x 314.468/ 9973119 hold-si f/scr o2.4 tb f/scrdriver shafts, 1 x 03.111.005/ 3725601 depth gauge f!scr 02-2.7 meas-range, 1 x 03.110.005/ 2708805 handle f/torque limiters 0.4/0.8/1.2nm, 1 x 311.430/ 2707911 handle w/quick-coupl l110, 1 x 399.071/ 5009647 reduc-forc w/point softlo l126, 1 x 399.074/ 5904217 reduc-forceps w/points wide softlo l127, 2 x 347-901/ 3632697 pliers flat-nosed pointed f/pi 1-2.4, 1 x 399.180/ 5909959 bonelever small short narrow tip wf6 16, 1 x 399.480/ 5910204 periost-elev slightly curv-blade straigh, 1 x 399-481/ t961615 periost-elev round edg w/3 curved blade, 1 x 323.029/ 2165825 lcp drill sleeve 2.4 w/scal-30 f/drill b, 1 x 03.111.000/ 13-5229 quick drill sleeve 2.4 w/scal f/drill bi, 1 x 03.111.750/ t102765 reduc-forc w/ball tips.
 
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Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES (USA)
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
michael cote
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key6998321
MDR Text Key90940767
Report Number2520274-2017-12556
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
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 Manufacturer11/13/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/27/2017
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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