MAUDE Adverse Event Report: SYNTHES TUTTLINGEN REDUCTION FORCEPS WITH POINTS BROAD-RATCHET

Catalog Number 398.41

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Additional narrative: no patient involvement reported.Event date: unknown.Device is an instrument and is not implanted/explanted.A service & repair evaluation/review was attempted; waiting for approval.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Service & repair documented that it was reported that two reduction forceps would not hold, and the bone spreader is broken.The issues were identified in sterile processing.There was no reported patient or procedure involvement.This complaint involves three devices.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: a service and repair evaluation was performed for the subject device.The customer reported the forceps would not hold.The synthes repair technician reported the locking sprocket not aligning correctly.¿bent¿ is the reason for repair.The item is not repairable per the inspection sheet.The cause of the complaint issue is unknown.The service and repair evaluation confirmed the complaint condition.The item will be forwarded to synthes customer quality for additional investigation.A service and repair history record review could not be completed because the subject device is a lot/batch controlled item.Therefore, a device history record review was attempted for the subject device lot number a7ia52, synthes lot number 4061645.Manufacturing location: (b)(4).The device history records are no longer available due to the age of the instrument (over 17 years old).Date of manufacture: week 52 in 1999.The exact date of manufacture is unknown.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A product development investigation was performed for the subject devices.Two 398.41 reduction forceps lot numbers a7oa42 and a7ia52 were returned and reported to no longer hold.One 399.10 lot number 2028 bone spreader was returned and reported to be broken.This complaint condition was likely caused by frequent repeated use and possible rough handling during surgery or sterile processing; however, this complaint is not likely a result of any design or manufacturing related deficiency.A visual inspection and drawing review were performed as part of this investigation.This complaint is confirmed.No new malfunctions were observed during the course of this investigation.The 398.41 reduction forceps are an instrument routinely used in the 2.4 mm lcp distal radius system (technique guide) and the 399.10 bone spreader is a general instrument with numerous applications.The forceps were returned and reported to not hold and the bone spreader was reported to be broken.These conditions are confirmed; the leaf spring of the bone spreader has broken off and was not returned, and a few teeth on each of the ratcheting mechanisms of the forceps are worn causing the mechanism to slip.The handles of the forceps are also somewhat bent.Lot a7oa42 was manufactured in 10/2005 and is over eleven years old.Lot a7ia52 was manufactured in 12/1999 and is over seventeen years old.The balance of the returned devices is fairly worn condition consistent with age of the devices.Drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned devices does agree with the complaint description.The complaint condition for the forceps can be replicated.Whether the complaint condition for the bone spreader can be replicated is not applicable.All measurements have been performed by calipers.The devices were received through service and repair as unrepairable where the complaint condition was also confirmed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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 BROAD-RATCHET
• Type of Device: FORCEPS
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6446498
• MDR Text Key: 71330144
• Report Number: 9680938-2017-10056
• Device Sequence Number: 1
• Product Code: HTD
• UDI-Device Identifier: 10886982201386
• UDI-Public: (01)10886982201386(10)A7IA52
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 398.41
• Device Lot Number: A7IA52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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