MAUDE Adverse Event Report: SYNTHES TUTTLINGEN LAMINA SPREADER F/T-PAL; FORCEPS, GEN & PLASTIC SURGERY

Catalog Number 03.812.040

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is not distributed in the united states, but is similar to device marketed in the usa.Device is an instrument and is not implanted/explanted.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material which was delivered as lot #864253 is corresponding to the specifications.The hardness was measured at the time of the manufacturing at 48,5 hrc and was found to be good.No ncrs were generated during production.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 europe reported an event (b)(6) as follows: it was reported that the spring on the handle is broken.The reported issue was discovered during surgery but before use on the patient.There was no surgical delay due to the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

A manufacturing evaluation was completed: the bottom spring between the handles has sheared off.The manufacturing evaluation shows that there were no issues during the manufacture of the product that would contribute to this complaint condition.The springs are pre bent to 15° before hardening and then require further bending at final assembly to reach the appropriate tension for the jaws to close when the handles are in the open position.A hardness test was performed on the broken spring and found to be conforming.A material analysis of the spring was conducted internally and confirmed that the material is corresponding to the delivered material certificate.Also the dimensions of the spring are conforming.No manufacturing issue was found during investigation.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: LAMINA SPREADER F/T-PAL
• Type of Device: FORCEPS, GEN & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5131148
• MDR Text Key: 28055696
• Report Number: 9680938-2015-10095
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Followup,Followup
• Report Date: 09/25/2015

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: 03.812.040
• Device Lot Number: T104531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/11/2015; 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2014
• 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