MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM; FORCEPS, MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 399.990

Device Problem Material Separation (1562)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Event Description

Report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the screws fell out.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: patient information not provided.The 510k#: 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).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.A review of the device history records has been requested.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

Device history records was conducted.The report indicates that the: manufacturing date: november 25th, 2010, 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.The raw material which was delivered as lot #hb423564 is corresponding to the specifications.The hardness was measured at the time of the manufacturing at 48,0 hrc and was found to be good.The screw was secured with a laser point after mounting.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

Product investigation summary: our investigation of the received article has shown that the instrument is in very good condition, but the "laser point" from the screw safety is broken, as mentioned in the complaint description.Also, it was noted that the screw connection is slightly damaged.Review of the device history record showed that there were no issues during the manufacture.The exact root cause cannot be determined for this reported problem, but it is highly likely that someone has manipulated this screw.No product fault could be detected.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.

• Brand Name: REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM
• Type of Device: FORCEPS, MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4734958
• MDR Text Key: 5822249
• Report Number: 9680938-2015-10037
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 399.990
• Device Lot Number: T954954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2010
• 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