MAUDE Adverse Event Report: SYNTHES BETTLACH 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM; APPLIANCE,FIXATION,NAIL

Catalog Number 413.028S

Device Problem Insufficient Information (3190)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient age was not provided by reporter.The date of event was reported as (b)(6) 2015; and the alert date reported as dec 16, 2015, however, it is unclear if this was the date the infection was confirmed or the date the symptoms began.Device is not distributed in the united states, but is similar to device marketed in the usa.Udi# is unavailable.The subject device is expected to be returned to the synthes manufacturer for evaluation.(b)(4).Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), 413.028s / 8938098, manufacturing date: 06 may 2014, expiry date: 01 april 2024.No ncr's were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute 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.

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported that a deep wound infection required surgery for debridement ((b)(6) 2015).Antibiotics, anticoagulants (clexane), analgesics and intensive care unit for physiotherapy.Recovery in progress.As it is not known what kind of surgery for debridement was done (unknown if the wound needed to be opened again) and as two dates are mentioned a second complaint file was opened to document the second intervention on (b)(6) 2015.Patient had an infection on the philos plate and the plate has been removed and she received antibiotics.This report is 12 of 17 for (b)(4).

Manufacturer Narrative

Other: udi: (b)(4).Device is marketed in the usa 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: 3.5MM TI LOCKING SCREW SELF-TAPPING 28MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5389658
• MDR Text Key: 36883675
• Report Number: 9612488-2016-10050
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: 413.028S
• Device Lot Number: 8938098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 73