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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LCP CONDYL-PL 2.4 SHAFT 7HO HE 2HO TI; PLATE,FIXATION,BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH LCP CONDYL-PL 2.4 SHAFT 7HO HE 2HO TI; PLATE,FIXATION,BONE Back to Search Results
Catalog Number 449.679
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Pain (1994); Injury (2348)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter phone number: (b)(6).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on an unknown date in 2020, two (2) lcp condyl-pl plates broke.The original procedure took place on (b)(6) 2020.It was reported that the physician believes that the patient did not follow postoperative indications.There is no further information available.Concomitant devices reported: cortex screw (part # 401.760, lot # unknown, quantity unknown), cortex screw (part # 401.762, lot # unknown, quantity unknown), cortex screw (part # 401.764, lot # unknown, quantity unknown), locking screw (part # 402.208, lot # unknown, quantity unknown), locking screw (part # 402.318, lot # unknown, quantity unknown), locking screw (part # 412.808, lot # unknown, quantity unknown), cortex screw (part # 402.872, lot # unknown, quantity unknown), cortex screw (part # 402.874, lot # unknown, quantity unknown).This report is for one (1) lcp condyl-pl 2.4 shaft 7ho he 2ho ti.This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The implant(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could be confirmed as the image provided shows a broken implant.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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
It was reported the patient experienced a polyfractured with hemothorax and the devices were implanted.The surgeon noted there seemed to be a lot of angulation after the initial placement of the devices.It was noted the breakage occurred between the third and fifth week post-surgery.It was noted there was a lack of consolidation due to the broken implants.The devices have not been explanted yet, but there is a plan to explant the devices.
 
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Brand Name
LCP CONDYL-PL 2.4 SHAFT 7HO HE 2HO TI
Type of Device
PLATE,FIXATION,BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10425154
MDR Text Key203498183
Report Number8030965-2020-06099
Device Sequence Number1
Product Code HRS
UDI-Device Identifier07611819157194
UDI-Public(01)07611819157194
Combination Product (y/n)N
PMA/PMN Number
K063049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/24/2020
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
Device Catalogue Number449.679
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/24/2020
Initial Date FDA Received08/19/2020
Supplement Dates Manufacturer Received08/27/2020
09/30/2020
Supplement Dates FDA Received09/22/2020
10/01/2020
Patient Sequence Number1
Treatment
CORTSCR Ø2.4 SELF-TAP L10 TAN; CORTSCR Ø2.4 SELF-TAP L12 TAN; CORTSCR Ø2.4 SELF-TAP L14 TAN; CORTSCR Ø2.7 SELF-TAP L12 TAN; CORTSCR Ø2.7 SELF-TAP L14 TAN; LCP CONDYL-PL 2.7 SHAFT 7HO HE 2HO TI; LOCKSCR Ø2.4 SELF-TAP L8 TAN; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L8 TAN; UNK - SCREWS: LOCKING; CORTSCR Ø2.4 SELF-TAP L10 TAN; CORTSCR Ø2.4 SELF-TAP L12 TAN; CORTSCR Ø2.4 SELF-TAP L14 TAN; CORTSCR Ø2.7 SELF-TAP L12 TAN; CORTSCR Ø2.7 SELF-TAP L14 TAN; LCP CONDYL-PL 2.7 SHAFT 7HO HE 2HO TI; LOCKSCR Ø2.4 SELF-TAP L8 TAN; LOCKSCR Ø2.7 HEAD LCP2.4 SELF-TAP L8 TAN; UNK - SCREWS: LOCKING
Patient Outcome(s) Required Intervention;
Patient Age51 YR
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