MAUDE Adverse Event Report: SYNTHES HAGENDORF EXTRACTSCR F/A2FN; EXTRACTOR

Catalog Number 03.010.373

Device Problems Failure To Adhere Or Bond (1031); Naturally Worn (2988)

Patient Problem Sedation (2368)

Event Date 04/28/2015

Event Type  Injury  

Event Description

Synthes europe reported an event in the (b)(6) as follows: it was reported that the connection between the extraction screw and the nail was ¿off¿ when the surgeon used a combined hammer during an extraction surgery.The extraction screw was reportedly used according to the technical guide.The surgeon had difficulty attaching the extraction screw to the nail properly from the first try.Eventually, the surgeon used another extraction screw to continue the surgery.The second extraction screw attached to the nail properly, which indicated that the first extraction screw had a problem.The tip of the first extraction screw was found to be worn during postoperative examination.There was 90 minute delay in the surgery due to the reported event.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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 review of the device history records has been requested.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 device history record review was performed for the subject device lot.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.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: involved product: one (1) x extractscr f/a2fn (03.010.373 / lot 7846155) our investigation shows that the instrument in question has heavy wear and tear on the outside thread.Also, some thread areas of the coating layer have disappeared, especially on the first 2-3mm.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the provided clinical information, it is impossible to determine the exact cause of this occurrence.It is likely that the device was not inserted when aligned into the nail.By this, the thread flanks got damaged, particularly in combination with an excessive force application.In such cases, it is necessary to follow the actual technique guide.Due to the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy.Due to the wear and tear signs, it is concluded that the cause of failure is not due to any manufacturing non-conformances.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.

Manufacturer Narrative

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.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: EXTRACTSCR F/A2FN
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4782364
• MDR Text Key: 21929238
• Report Number: 3003875359-2015-10223
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/28/2015

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: 03.010.373
• Device Lot Number: 7846155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 05/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/20/2015; 06/11/2015; 06/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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
• Patient Outcome(s): Required Intervention