• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTING PLIERS PLIERS,SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC CUTTING PLIERS PLIERS,SURGICAL Back to Search Results
Catalog Number 391.931
Device Problems Break (1069); Crack (1135); Material Integrity Problem (2978)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Reportability changed based on investigation result. Deemed reportable august 2, 2019. Original alert date june 6, 2019. Investigation summary: the cutting pliers (part # 391. 931, lot # 1003) was received at us cq. The cutting edged appeared in good shape however the adjacent cushions were both damaged. One of the cushions had a crack, and the other cushion had a significant piece of it broken off. There are light scratches along the body of the device that is consistent with wear. The received condition is consistent with the complaint condition thus the complaint is confirmed. Dimensional inspection: due to the age of the device (16yrs) and a lack of relevant information on the source control drawing, a dimensional inspection was not performed. Document/specification review: drawing(s) reviewed: (current & manufactured revisions) no issues. Manufacturing record evaluation: the cutting pliers (part # 391. 931, lot # 1003) was manufactured at the (b)(6) site on 02-apr-2003. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified. Conclusion: the complaint was confirmed for the cutting pliers (part # 391. 931, lot # 1003). The device was returned with one of the cushions broken and the other cracked. There were light cosmetic issues along the body that is consistent with normal wear. Although no definite root cause could be determined, it is possible that the device experienced unintended forces during use over its lifecycle. There was no indication that a design or manufacturing issue contributed to the complaint. No design issues were observed during the document/specification review. 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 history review: part 391. 931. Lot 1003. Manufacturing site: (b)(6). Manufacturing date: 02. Apr. 2003. No ncrs were generated during production. Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 on (b)(6) 2019, during a routine inspection at the sterile processing department, the cutting edges of the variable angle locking compression plate bending plier were damaged. There was no patient involvement. This is report 1 of 1 for (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCUTTING PLIERS
Type of DevicePLIERS,SURGICAL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
SYNTHES HAEGENDORF GMBH-CN
im bifang 6
haegendorf 4614
SZ 4614
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8861315
MDR Text Key153366965
Report Number2939274-2019-59531
Device Sequence Number1
Product Code HTC
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 06/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number391.931
Device LOT Number1003
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/01/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/02/2003
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-