MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC HOLDING SLEEVE-LONG FOR MATRIX; MISC ORTHO SURGICAL INSTR

Catalog Number 03.632.036

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The returned matrix holding sleeve was examined and the threaded tip was found to be broken and missing a segment.No dimensional analysis was able to be completed due to post-manufacturing damage.No definitive root cause was able to be determined; the failure mode is consistent with the application of an off-axis load while engaging a screw.The complaint condition was unable to be replicated due to post-manufacturing damage.

Event Description

It was reported that upon routine inspection of field equipment three holding sleeves were found damaged.No patient involvement.The returned matrix holding sleeve was examined and the threaded tip was found to be broken and missing a segment.

• Brand Name: HOLDING SLEEVE-LONG FOR MATRIX
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7224748
• MDR Text Key: 98756859
• Report Number: 2939274-2018-50409
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034718941
• UDI-Public: (01)10705034718941(10)H058019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.632.036
• Device Lot Number: H058019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1