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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: TRAUMA; PLATE, FIXATION, BONE
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SYNTHES GMBH UNK - PLATES: TRAUMA; PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK - PLATES: TRAUMA
Device Problem Break (1069)
Patient Problems Pain (1994); Discomfort (2330); Non-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Additional narrative: this report is for an unk - nails/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Patient initiated complaint: the patient stated, " it was broken in my legs in (b)(6) they put nail in my legs and it ended up breaking.They have to remove that part from my leg and put on (b)(6) 2021.I have rehab and doctors are care ever since.I appreciate a phone call.Please make synthes aware of the updated information.The patient did not know the manufacturer of the plate that broke.Since the number he called originally was provided by the surgeon who revised the broken plate, it would be a fair assumption that the plate may be a synthes plate.It should be noted that there may have been some misunderstandings in communication due to difficulty in hearing.".
 
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.
 
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d10: date of concomitant therapy is (b)(6) 2021.H6: the device lot number is unknown; therefore, a device history review could not be performed.If more information become available, the record will be re-assessed.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received photo(s).Visual analysis of the photo revealed that unknown plate had a broken condition, this condition is related with the customer complaint regarding a broken plate.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for the plate.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
 
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Brand Name
UNK - PLATES: TRAUMA
Type of Device
PLATE, FIXATION, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13713470
MDR Text Key288775844
Report Number8030965-2022-01477
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 Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK - PLATES: TRAUMA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient SexMale
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