MAUDE Adverse Event Report: SYNTHES MONUMENT ALUMINUM HOHMANN RETRACTOR 35MM WIDTH

Catalog Number 03.100.108

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No patient or procedural involvement.Event date: unknown.Implant and explant dates: device is an instrument and is not implanted or explanted.The complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn as no product was received.Mfg date: the lot was distributed in three (3) separate batches with release dates as follows: june 21, 2014 ((b)(4) parts), june 21, 2014 ((b)(4) parts), and july 10, 2014 ((b)(4) parts) device history record review: manufacturing date: june 21, 2014.Packaged by: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Device 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 four (4) aluminum hohmann retractors were found with the tips broken off.The location of the missing fragments is unknown.It was unknown when or how the breakages occurred as the issue was noticed after sterile processing.No reported patient or surgical involvement.This report is 1 of 4 for (b)(4).

• Brand Name: ALUMINUM HOHMANN RETRACTOR 35MM WIDTH
• Type of Device: RETRACTOR
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5477826
• MDR Text Key: 39639942
• Report Number: 1719045-2016-10185
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.100.108
• Device Lot Number: 7653978
• Other Device ID Number: (01)10886982071064(10)7653978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2014
• 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