MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNIVERSAL CHUCK WITH T-HANDLE; MISC, SURGICAL, ORTHO, INSTRUMENT

Catalog Number 393.100

Device Problems Device-Device Incompatibility (2919); Device Handling Problem (3265)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.State: (b)(6).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive 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)(4) as follows: it was reported that part number 393.100/universal chuck with t-handle was not working/gripping the steinman pin during repeated tries.Surgery delayed only three minutes due to the reported.Unknown if fragments were generated or if procedure was successfully completed by an alternative device.Concomitant device reported: unknown steinmann pin (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is for one (1) universal chuck with t-handle.This report is 1 of 1 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.H11 corrected information: b4, h6.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.

• Brand Name: UNIVERSAL CHUCK WITH T-HANDLE
• Type of Device: MISC, SURGICAL, ORTHO, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9168976
• MDR Text Key: 196211304
• Report Number: 2939274-2019-61319
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07611819025196
• UDI-Public: (01)07611819025196
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 393.100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Patient Sequence Number: 1
• Treatment: STEINMANN PIN