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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: LOCKING; SCREW, FIXATION, BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: LOCKING; SCREW, FIXATION, BONE Back to Search Results
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
It was reported that, the patient had an infected non-union humerus with broken unknown screws.Concomitant device reported: lcp proximal periarticular proximal humerus plate(part# 02.123.027; lot# unknown; quantity: unknown) unk - screws (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) unk - screws: trauma.This is report 11 of 11 for complaint (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this report is for an unk - screws: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.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
It was reported that, the patient had an infected non-union humerus with broken unknown screws.Concomitant device reported: lcp proximal periarticular proximal humerus plate(part# 02.123.027; lot# unknown; quantity: unknown) unk - screws (part# unknown; lot# unknown; quantity: unknown) this report is for one (1) unk - screws: trauma.This is report 11 of 11 for complaint (b)(4).
 
Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: this report is for an unk - screws: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.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.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.
 
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.H6: investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the provided product photographs.Examination of the provided picture found the reported locking screw appears to be broken.No other defect was identified.A definitive assignable root cause could not be determined based on the provided information.As the device was not returned, an as-received condition could not be assessed.And a dimensional inspection document/specification review were not completed 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.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
During manufacturer's preliminary photo investigation it was identified that the reported locking screw appears to be broken.
 
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Brand Name
UNK - SCREWS: LOCKING
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES SALZBURG
vorgartenstrasse 206b
salzburg 1020 WIEN
AU   1020 WIEN
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13119637
MDR Text Key286133172
Report Number2939274-2021-07297
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
3.5 LCP PERIARTIC PROX HUM PL 8 H/199/LT; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
Patient SexFemale
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