MAUDE Adverse Event Report: SYNTHES HAGENDORF EXTRACTSCR F/TIBIAL+FEM NAILS; EXTRACTOR

Catalog Number 03.010.000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).The 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot.Manufacturing location: synthes (b)(4).Date of manufacture: dec 21, 2015.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.(b)(4) was utilized for the unsuccessful removal of the implant need to schedule another surgery.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)(4) reported an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2017, it was not possible to extract the rod with the extraction screw.The surgical procedure had to be rescheduled due to the reported event.Concomitant reported part: 1x rod (part and lot unknown).This is report 1 of 1 for com-(b)(4).

Manufacturer Narrative

Patient requested hardware removal.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.

Event Description

It is reported patient requested removal of hardware.No reported issue with the implant.

• Brand Name: EXTRACTSCR F/TIBIAL+FEM NAILS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6431343
• MDR Text Key: 70767992
• Report Number: 3003875359-2017-10142
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819160361
• UDI-Public: (01)07611819160361(10)9730765
• 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: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.000
• Device Lot Number: 9730765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2015
• 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
• Treatment: UNKNOWN ROD, QUANTITY 1
• Patient Outcome(s): Required Intervention