MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH POINTS RATCHET 200MM

Catalog Number 399.98

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No reported patient involvement.Device is an instrument and is not implanted or explanted.(b)(6).Service and repair evaluation: the customer reported the points were damaged.The repair technician reported the one of the points of the forceps broke.The broken tip is the reason for repair.The item is not repairable.The cause of the issue is unknown.The item will be forwarded for further investigation.Product investigation summary: the reduction forceps with points is an instrument routinely used in numerous systems including the 3.5mm lcp distal humerus plate system.The relevant product drawing was reviewed during the investigation and the design, materials, and finishing processes were found to be appropriate for the intended use of the devices.The complaint that the tip of the instrument was broken was able to be confirmed upon investigation.The balance of the returned device is in fairly worn condition with several scratches and other signs of wear along the length of the forceps.The forceps were manufactured in 1998.It is likely that regular wear and excessive force over the course of 18 years contributed to the complaint condition.Service history record review: no service history review can be performed as this is a lot controlled item.The manufacture date of this item is may 28, 1998.The source of the manufacture date is the release to warehouse date.The service history evaluation is unconfirmed.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

Device report from synthes (b)(6) reports an event as follows: it was originally reported that a pair of locking pliers (180mm) were not locking properly.Also, a pair of reduction forceps reportedly had damaged points.The issues were discovered during the cleaning process within the medical device reprocessing department.There was no reported patient or surgical involvement.Upon investigation of the returned devices, however, it was determined that a small fragment of the toothed portion of the locking pliers was missing.Additionally, the tip of the reduction forceps was found to be broken.Based upon this updated information, a reassessment of the reportability was conducted.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.A device history record (dhr) review was attempted for the subject device lot number but could not be completed due to the age of the instrument.The subject device was manufactured on may 16, 1998.The synthes manufacturing location was identified during the dhr review.The previously reported date was the released to warehouse date.May 16, 1998 is the actual date of manufacture.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 POINTS RATCHET 200MM
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen PA 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: 5504133
• MDR Text Key: 40474023
• Report Number: 2520274-2016-11674
• Device Sequence Number: 1
• Product Code: HTC
• 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,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

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: 399.98
• Device Lot Number: A7HA20
• Other Device ID Number: (01)10886982203168(10)A7HA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2016
• Initial Date FDA Received: 03/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/1998
• 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