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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM; NAIL, FIXATION, BONE
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SYNTHES GMBH 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 212.119
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Additional product code: ktt.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6) as follows: it was reported that "upon arriving at the material delivered to patient by j&j voucher.It was verified from the list that the 3.5 locked screws were incomplete and in varying quantities according to the size of each screw.The vast majority of them contained only 4 units of each screw, plus a size containing only 03 units in the template, (size 28 =3 units).Only two sizes were complete which would be a total of 6 units each.Full screws were; *screw block 3.5 x24 =6 units.*screw block 3.5x40 =6 units.The sales representative was contacted and explained the situation, he informed to me that only one locked screw was missing.The surgical schedule was a bilateral procedure and that the issue of having only 4 units of each size could impact the surgery as it was a bilateral procedure and needed more of each size.When the team arrived at the operating room, the surgeon was informed of the number of screws available in the template, according to each size.The surgeon was not pleased and expressed his frustration.It was also reported that for this reason, according to he decided not to go through the operation of the left hip of the patient.The surgery was performed on the patient's right side only.If possible, standardize all of these screw templates with the same amount of screws, which would be 06 units of each.This way, future problems may be avoided with new 3.5 blocked screws shortages, specifically in surgeries that are bilateral." patient status/ outcome / consequences was only one part of the surgery was done because there was not enough material to perform the second part of the body.The surgery was bilateral.This complaint involves seventy-two (72) devices.This report is for (1) 3.5mm locking screw slf-tpng w/stardrive(tm) recess 45mm.This report is 15 of 18 for (b)(4).Related product complaint: (b)(4).
 
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Brand Name
3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 45MM
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key12052635
MDR Text Key268250144
Report Number8030965-2021-05250
Device Sequence Number1
Product Code JDS
UDI-Device Identifier07611819125926
UDI-Public(01)07611819125926
Combination Product (y/n)N
PMA/PMN Number
K072095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number212.119
Was Device Available for Evaluation? No
Date Manufacturer Received08/23/2021
Patient Sequence Number1
Treatment
LOCKSCR Ø3.5 SELF-TAP L30 SST; LOCKSCR Ø3.5 SELF-TAP L30 SST; LOCKSCR Ø3.5 SELF-TAP L30 SST; LOCKSCR Ø3.5 SELF-TAP L30 SST; LOCKSCR Ø3.5 SELF-TAP L30 SST; LOCKSCR Ø3.5 SELF-TAP L30 SST; LOCKSCR Ø3.5 SELF-TAP L35 SST; LOCKSCR Ø3.5 SELF-TAP L35 SST; LOCKSCR Ø3.5 SELF-TAP L35 SST; LOCKSCR Ø3.5 SELF-TAP L35 SST; LOCKSCR Ø3.5 SELF-TAP L35 SST; LOCKSCR Ø3.5 SELF-TAP L35 SST; LOCKSCR Ø3.5 SELF-TAP L45 SST; LOCKSCR Ø3.5 SELF-TAP L45 SST; LOCKSCR Ø3.5 SELF-TAP L45 SST; LOCKSCR Ø3.5 SELF-TAP L45 SST; LOCKSCR Ø3.5 SELF-TAP L45 SST
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