MAUDE Adverse Event Report: SYNTHES GMBH EXPERT A2FN Ø11 R CANN L420 TAN LIGHT GR ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.009.464

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. (nail damage) couldn't be verified. Product was not returned therefore no further investigation possible. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available (information or/and material), the investigation will be updated as applicable. A device history record (dhr) review was conducted: part: 04. 009. 464s, lot: l902819, manufacturing site: (b)(4), release to warehouse date: 18. June 2018, expiry date: 01. June 2028. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified. 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

Device report from synthes reports an event in (b)(6)india as follows: it was reported that during an unknown procedure on an unknown date in 2020, an expert a2fn nail was stuck in femoral canal. Surgeon used nail extractor to remove the nail, however in the process of removal the nail got damaged/cracked. Another nail was used to finish the case. There was a surgical delay of thirty (30) minutes due to the reported event. Procedure was successfully completed. Patient outcome is reported as stable. Concomitant device reported: nail extractor(part # 03. 010. 373, lot # unknown, quantity 1). This report is for one (1) expert a2fn ø11 r cann l420 tan light gr. This is report 1 of 1 for complaint (b)(4).

• Brand Name: EXPERT A2FN Ø11 R CANN L420 TAN LIGHT GR
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10968621
• MDR Text Key: 220238586
• Report Number: 8030965-2020-09498
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.009.464
• Device Lot Number: L902819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 12/08/2020 Patient Sequence Number: 1

Treatment

NAIL EXTRACTOR